HypotensionNCT02726620
Decision Support for Intraoperative Low Blood Pressure
A study testing Attending real-time decision support, In-room real-time decision support and Attending feedback emails in people with Hypotension, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hypotension
- What is being tested?
- Attending real-time decision support, In-room real-time decision support and Attending feedback emails
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,435 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 29 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 60 years and older
- Inpatients
- Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia
Who cannot join
- Pre-existing end-stage renal disease: operationalized as a preoperative need for dialysis
- The following surgical procedures: renal surgery, cardiac surgery, organ transplantation, ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures.
- small non-invasive or minimally-invasive procedures will also be excluded, operationalized as excluding procedures with a surgical time of less than twenty minutes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury.
Read the detailed description
Blood pressure management is an important part of anesthesia. Many factors contribute to a change in blood pressure during a surgical procedure, such as blood loss, manipulation by surgeons, and there are several mechanisms through which anesthesia itself changes blood pressure. Although a high blood pressure also occurs during anesthesia, most of these factors lower a patient's blood pressure. When a patient's blood pressure becomes too low, the internal organs become at risk of receiving not enough blood (low perfusion or hypoperfusion). This low perfusion state can result in organ damage (ischemia) because of an insufficient supply of oxygen and glucose. Hence the important task of anesthesia providers to maintain the blood pressure of patients, using a wide range of drugs and other interventions.
A big challenge in blood pressure management is to know when a low blood pressure indeed results in low perfusion of organs. There is a large variation between patients in how susceptible they are to low blood pressure, as well as a difference between the organs in how easily they are damaged because of low perfusion. Elder patients, or patients with preexisting hypertension, heart problems or other cardiovascular diseases are more prone to a low blood pressure and are more likely to develop organ ischemia when there is a low blood pressure. The kidneys, the heart and the brain are the organs that are most at risk of organ damage. As one cannot measure the perfusion states of individual organs in individual patients, it is very difficult to know 'how low to go' with a patient's blood pressure.
Recent studies have used large datasets of patients to demonstrate that there is statistical association between low blood pressure during surgery and various types of organ injury. As patients are already treated for low blood pressure by anesthesia providers, this suggests that patients have low organ perfusion states despite the current treatment standards. A patient's blood pressure is not simply a dial that can be adjusted to a specific level. Finding the right level of interventions can be difficult in some patients. Consequently, lower blood pressures are common in anesthesia, even with the current standards of blood pressure management.
In this proposed study the investigators will implement two forms of decision support to assist anesthesia providers in blood pressure management. The decision support aims to educate anesthesia providers about the risks of low blood pressures in direct relation to the patients that they treat. One form of decision support will provide automated notifications through pagers and through the anesthesia information management system. These automated notifications pop up when the patient's blood pressure drops below a level that is associated with a risk of organ injury, and thus alerts the anesthesia provider of the blood pressure and its associated risk. The second form of decision support will send a postoperative email the day after the procedure when the patient has had a low blood pressure for particular duration. This email then provides feedback to the anesthesia provider by informing them of the increased risks of organ injury that are associated with that low blood pressure.
The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical Center (VUMC). The change in patient outcome will primarily be studied through the occurrence of acute kidney injury in the first days following the procedure at the VUMC. The change in blood pressure management (provider behavior) will be studied by observing the depth and duration of low pressures during anesthesia, and the number of interventions that have been used to treat the blood pressure. Patient outcome will be studied by comparison of a baseline phase - before the decision support is implemented and uses historic data- and the intervention phase - the period during which the intervention is active. Only routinely collected clinical data will be used for these analyses: no additional data collection is required.
As it is impossible to know which form of decision support will be the most effective, the first three months of the intervention period will be a 'nested cluster-randomized trial'. The anesthesia providers (not the patients) will be randomized to either the automated notifications or the feedback emails. After three months all anesthesia providers will receive both forms of decision support for the remainder of the intervention period. The reason why anesthesia providers are randomized only during the first three months is that cross-over or contamination between the two groups is expected. This contamination could make it impossible to study the effect of the decision support on patient outcome, as there will be no longer any difference between the study groups.
- Conditions
- Hypotension
- Being tested
- Attending real-time decision support, In-room real-time decision support, Attending feedback emails, In-room provider feedback emails, Anesthesia Information Management System (AIMS)
- Keywords
- Decision support, Decision Support Systems, Clinical, Decision Support Techniques, Hypotension, Intraoperative Hypotension, Acute Kidney Injury, Postoperative Mortality, Blood Pressure
- Medical subject headings
- Hypotension, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attending real-time decision supportProcedure or surgery
Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.
In-room real-time decision supportProcedure or surgery
Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.
Attending feedback emailsProcedure or surgery
Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
In-room provider feedback emailsProcedure or surgery
In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
Anesthesia Information Management System (AIMS)Device
The anesthesia electronic record keeping system
Perioperative Data Warehouse (PDW)Device
The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.
General anesthesiaProcedure or surgery
Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
Pager systemDevice
The mobile pager system through which alerts can be sent
Central neuraxial anesthesiaProcedure or surgery
Also called Regional anesthesia, Spinal anesthesia, Intrathecal anesthesia, Subarachnoid anesthesia
Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
Non-cardiac surgeryProcedure or surgery
Any surgical intervention that is not aimed at surgical correction of the heart
PropofolDrug
Anesthetic drug used to maintain general anesthesia
SevofluraneDrug
Anesthetic drug used to maintain general anesthesia
DesfluraneDrug
Anesthetic drug used to maintain general anesthesia
IsofluraneDrug
Anesthetic drug used to maintain general anesthesia
EphedrineDrug
Cardiovascular drug used to treat intraoperative hypotension
PhenylephrineDrug
Cardiovascular drug used to treat intraoperative hypotension
NorepinephrineDrug
Cardiovascular drug used to treat intraoperative hypotension
EpinephrineDrug
Cardiovascular drug used to treat intraoperative hypotension
DobutamineDrug
Cardiovascular drug used to treat intraoperative hypotension
DopamineDrug
Cardiovascular drug used to treat intraoperative hypotension
IsoproterenolDrug
Cardiovascular drug used to treat intraoperative hypotension
MilrinoneDrug
Cardiovascular drug used to treat intraoperative hypotension
AtropineDrug
Cardiovascular drugs used to treat intraoperative hypotension
GlycopyrrolateDrug
Cardiovascular drug used to treat intraoperative hypotension
VasopressinDrug
Cardiovascular drug used to treat intraoperative hypotension
TerlipressinDrug
Cardiovascular drug used to treat intraoperative hypotension
Sodium Chloride 0.9%Drug
Intravenous fluid used to treat intraoperative hypotension
Ringer's lactateDrug
Intravenous fluid used to treat intraoperative hypotension
Hydroxyethyl starch solutionsDrug
Intravenous fluid used to treat intraoperative hypotension
Fresh Frozen PlasmaDrug
Intravenous fluid used to treat intraoperative hypotension
Packed Red Blood CellsDrug
Intravenous fluid used to treat intraoperative hypotension
Albumin solutionsDrug
Intravenous fluid used to treat intraoperative hypotension
Plasma-LyteDrug
Intravenous fluid used to treat intraoperative hypotension
LidocaineDrug
Also called Lignocaine
Local anesthetic used for central neuraxial anesthesia.
BupivacaineDrug
Local anesthetic used for central neuraxial anesthesia.
LevobupivacaineDrug
Local anesthetic used for central neuraxial anesthesia.
RopivacaineDrug
Local anesthetic used for central neuraxial anesthesia.
MepivacaineDrug
Local anesthetic used for central neuraxial anesthesia.
TetracaineDrug
Local anesthetic used for central neuraxial anesthesia.
PrilocaineDrug
Local anesthetic used for central neuraxial anesthesia.
ProcaineDrug
Local anesthetic used for central neuraxial anesthesia.
ChloroprocaineDrug
Local anesthetic used for central neuraxial anesthesia.
BenzocaineDrug
Local anesthetic used for central neuraxial anesthesia.
ArticaineDrug
Local anesthetic used for central neuraxial anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Hypotension decision support | Experimental | The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. Receives: Procedure: Attending real-time decision support; Procedure: In-room real-time decision support; Procedure: Attending feedback emails; Procedure: In-room provider feedback emails; Device: Anesthesia Information Management System (AIMS); Device: Perioperative Data Warehouse (PDW); Procedure: General anesthesia; Device: Pager system; Procedure: Central neuraxial anesthesia; Procedure: Non-cardiac surgery; Drug: Propofol; Drug: Sevoflurane; Drug: Desflurane; Drug: Isoflurane; Drug: Ephedrine; Drug: Phenylephrine; Drug: Norepinephrine; Drug: Epinephrine; Drug: Dobutamine; Drug: Dopamine; Drug: Isoproterenol; Drug: Milrinone; Drug: Atropine; Drug: Glycopyrrolate; Drug: Vasopressin; Drug: Terlipressin; Drug: Sodium Chloride 0.9%; Drug: Ringer's lactate; Drug: Hydroxyethyl starch solutions; Drug: Fresh Frozen Plasma; Drug: Packed Red Blood Cells; Drug: Albumin solutions; Drug: Plasma-Lyte; Drug: Lidocaine; Drug: Bupivacaine; Drug: Levobupivacaine; Drug: Ropivacaine; Drug: Mepivacaine; Drug: Tetracaine; Drug: Prilocaine; Drug: Procaine; Drug: Chloroprocaine; Drug: Benzocaine; Drug: Articaine |
| Usual care group | Active comparator | The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). Receives: Procedure: General anesthesia; Procedure: Central neuraxial anesthesia; Procedure: Non-cardiac surgery; Drug: Propofol; Drug: Sevoflurane; Drug: Desflurane; Drug: Isoflurane; Drug: Ephedrine; Drug: Phenylephrine; Drug: Norepinephrine; Drug: Epinephrine; Drug: Dobutamine; Drug: Dopamine; Drug: Isoproterenol; Drug: Milrinone; Drug: Atropine; Drug: Glycopyrrolate; Drug: Vasopressin; Drug: Terlipressin; Drug: Sodium Chloride 0.9%; Drug: Ringer's lactate; Drug: Hydroxyethyl starch solutions; Drug: Fresh Frozen Plasma; Drug: Packed Red Blood Cells; Drug: Albumin solutions; Drug: Plasma-Lyte; Drug: Lidocaine; Drug: Bupivacaine; Drug: Levobupivacaine; Drug: Ropivacaine; Drug: Mepivacaine; Drug: Tetracaine; Drug: Prilocaine; Drug: Procaine; Drug: Chloroprocaine; Drug: Benzocaine; Drug: Articaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Acute Kidney Injury
Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.
Measured: Within 7 days after surgery
Secondary outcomes (39)
30-day Mortality
Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days)
Measured: 30 days after surgery
In-hospital Mortality
Hospital mortality rate during a single hospital admission after the surgery
Measured: All postoperative days during a single hospital admission, expected median of 5 days
Postoperative Acute Kidney Injury Stage 2
Postoperative Acute Kidney Injury (AKI), Stage II or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.
Measured: Within 7 days after surgery
Postoperative Rise in Creatinine Levels
Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported.
Measured: Within 7 days after surgery
Incidence of a MAP < 60 mmHg
Incidence of a mean arterial pressure (MAP) < 60 mmHg during anesthesia for 1 minute or more.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg
Incidence of a mean arterial pressure (MAP) < 55 mmHg during anesthesia for 1 minute or more.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg
Incidence of a mean arterial pressure (MAP) < 50 mmHg during anesthesia for 1 minute or more.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 60 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg for > 10 Minutes
Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 60 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg for > 20 Minutes
Incidence of a mean arterial pressure (MAP) < 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Estimated Intraoperative Blood Loss
The estimated blood loss in mL during the surgical procedure
Measured: During the surgical procedure: an expected average of 2 hours
Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes).
Measured: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Average concentrations of propofol infusion rates during MAP < 65 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Average concentrations of propofol infusion rates during MAP < 60 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Average concentrations of propofol infusion rates during MAP < 55 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Average concentrations of propofol infusion rates during MAP < 50 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Ephedrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosages would be meaningless.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Phenylephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Glycopyrrolate
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Epinephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Norepinephrine
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in <1% of cases are not reported, as the average dosage would be meaningless.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 65 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 60 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 55 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 50 mmHg
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intraoperative Administration of Intravenous Fluids
Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure.
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Average concentrations of inhalational anesthesia during MAP < 65 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Average concentrations of inhalational anesthesia during MAP < 60 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Average concentrations of inhalational anesthesia during MAP < 55 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Average concentrations of inhalational anesthesia during MAP < 50 mmHg episodes
Measured: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study start5 Jan 2017
- Primary completion31 Dec 2017
- Study completion29 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- It is an interrupted time-series of a decision support package intervention that aims to study the the effect of the decision support package on patient outcome. The effects of the individual decision support components of the package on healthcare provider behavior will be studied in a nested cluster-randomized trial: in the first month the attending anesthesiologists will be randomized to near-realtime notifications or feedback emails; in the second month in-room providers will be randomized to near-realtime notifications or feedback emails. Starting month four all providers will receive both near-realtime notifications and feedback emails.
- Masking
- None (open label)
- Enrolment
- 22,435 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht
- Responsible party
- Principal investigator, Jonathan Wanderer, Vanderbilt University Medical Center
- Investigators
- Jonathan P Wanderer, MD, MPhil, Principal investigator, Vanderbilt University Medical Center, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726620
- Sponsor's protocol ID
- 160131
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2016
- Last updated
- 16 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Support for Intraoperative Low Blood Pressure
- ClinicalTrials.gov ID
- NCT02726620
- Acronym / sponsor ID
- 160131
- Conditions
- Hypotension
- Keywords
- Decision support, Decision Support Systems, Clinical, Decision Support Techniques, Hypotension, Intraoperative Hypotension, Acute Kidney Injury, Postoperative Mortality, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22,435 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 29 Dec 2018 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Posted 16 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a decision support system can improve the adherence to thresholds for low blood pressure by anesthesia providers, which in turn prevents their patients from having organ injury.
Detailed description
Blood pressure management is an important part of anesthesia. Many factors contribute to a change in blood pressure during a surgical procedure, such as blood loss, manipulation by surgeons, and there are several mechanisms through which anesthesia itself changes blood pressure. Although a high blood pressure also occurs during anesthesia, most of these factors lower a patient's blood pressure. When a patient's blood pressure becomes too low, the internal organs become at risk of receiving not enough blood (low perfusion or hypoperfusion). This low perfusion state can result in organ damage (ischemia) because of an insufficient supply of oxygen and glucose. Hence the important task of anesthesia providers to maintain the blood pressure of patients, using a wide range of drugs and other interventions.
A big challenge in blood pressure management is to know when a low blood pressure indeed results in low perfusion of organs. There is a large variation between patients in how susceptible they are to low blood pressure, as well as a difference between the organs in how easily they are damaged because of low perfusion. Elder patients, or patients with preexisting hypertension, heart problems or other cardiovascular diseases are more prone to a low blood pressure and are more likely to develop organ ischemia when there is a low blood pressure. The kidneys, the heart and the brain are the organs that are most at risk of organ damage. As one cannot measure the perfusion states of individual organs in individual patients, it is very difficult to know 'how low to go' with a patient's blood pressure.
Recent studies have used large datasets of patients to demonstrate that there is statistical association between low blood pressure during surgery and various types of organ injury. As patients are already treated for low blood pressure by anesthesia providers, this suggests that patients have low organ perfusion states despite the current treatment standards. A patient's blood pressure is not simply a dial that can be adjusted to a specific level. Finding the right level of interventions can be difficult in some patients. Consequently, lower blood pressures are common in anesthesia, even with the current standards of blood pressure management.
In this proposed study the investigators will implement two forms of decision support to assist anesthesia providers in blood pressure management. The decision support aims to educate anesthesia providers about the risks of low blood pressures in direct relation to the patients that they treat. One form of decision support will provide automated notifications through pagers and through the anesthesia information management system. These automated notifications pop up when the patient's blood pressure drops below a level that is associated with a risk of organ injury, and thus alerts the anesthesia provider of the blood pressure and its associated risk. The second form of decision support will send a postoperative email the day after the procedure when the patient has had a low blood pressure for particular duration. This email then provides feedback to the anesthesia provider by informing them of the increased risks of organ injury that are associated with that low blood pressure.
The study will look at both a change in patient outcome and a change in blood pressure management and will be performed at the Vanderbilt University Medical Center (VUMC). The change in patient outcome will primarily be studied through the occurrence of acute kidney injury in the first days following the procedure at the VUMC. The change in blood pressure management (provider behavior) will be studied by observing the depth and duration of low pressures during anesthesia, and the number of interventions that have been used to treat the blood pressure. Patient outcome will be studied by comparison of a baseline phase - before the decision support is implemented and uses historic data- and the intervention phase - the period during which the intervention is active. Only routinely collected clinical data will be used for these analyses: no additional data collection is required.
As it is impossible to know which form of decision support will be the most effective, the first three months of the intervention period will be a 'nested cluster-randomized trial'. The anesthesia providers (not the patients) will be randomized to either the automated notifications or the feedback emails. After three months all anesthesia providers will receive both forms of decision support for the remainder of the intervention period. The reason why anesthesia providers are randomized only during the first three months is that cross-over or contamination between the two groups is expected. This contamination could make it impossible to study the effect of the decision support on patient outcome, as there will be no longer any difference between the study groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is an interrupted time-series of a decision support package intervention that aims to study the the effect of the decision support package on patient outcome. The effects of the individual decision support components of the package on healthcare provider behavior will be studied in a nested cluster-randomized trial: in the first month the attending anesthesiologists will be randomized to near-realtime notifications or feedback emails; in the second month in-room providers will be randomized to near-realtime notifications or feedback emails. Starting month four all providers will receive both near-realtime notifications and feedback emails.
| Arm | Type | Receives |
|---|---|---|
| Hypotension decision support | Experimental | Procedure: Attending real-time decision support, Procedure: In-room real-time decision support, Procedure: Attending feedback emails, Procedure: In-room provider feedback emails, Device: Anesthesia Information Management System (AIMS), Device: Perioperative Data Warehouse (PDW), Procedure: General anesthesia, Device: Pager system, Procedure: Central neuraxial anesthesia, Procedure: Non-cardiac surgery, Drug: Propofol, Drug: Sevoflurane, Drug: Desflurane, Drug: Isoflurane, Drug: Ephedrine, Drug: Phenylephrine, Drug: Norepinephrine, Drug: Epinephrine, Drug: Dobutamine, Drug: Dopamine, Drug: Isoproterenol, Drug: Milrinone, Drug: Atropine, Drug: Glycopyrrolate, Drug: Vasopressin, Drug: Terlipressin, Drug: Sodium Chloride 0.9%, Drug: Ringer's lactate, Drug: Hydroxyethyl starch solutions, Drug: Fresh Frozen Plasma, Drug: Packed Red Blood Cells, Drug: Albumin solutions, Drug: Plasma-Lyte, Drug: Lidocaine, Drug: Bupivacaine, Drug: Levobupivacaine, Drug: Ropivacaine, Drug: Mepivacaine, Drug: Tetracaine, Drug: Prilocaine, Drug: Procaine, Drug: Chloroprocaine, Drug: Benzocaine, Drug: ArticaineThe intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. |
| Usual care group | Active comparator | Procedure: General anesthesia, Procedure: Central neuraxial anesthesia, Procedure: Non-cardiac surgery, Drug: Propofol, Drug: Sevoflurane, Drug: Desflurane, Drug: Isoflurane, Drug: Ephedrine, Drug: Phenylephrine, Drug: Norepinephrine, Drug: Epinephrine, Drug: Dobutamine, Drug: Dopamine, Drug: Isoproterenol, Drug: Milrinone, Drug: Atropine, Drug: Glycopyrrolate, Drug: Vasopressin, Drug: Terlipressin, Drug: Sodium Chloride 0.9%, Drug: Ringer's lactate, Drug: Hydroxyethyl starch solutions, Drug: Fresh Frozen Plasma, Drug: Packed Red Blood Cells, Drug: Albumin solutions, Drug: Plasma-Lyte, Drug: Lidocaine, Drug: Bupivacaine, Drug: Levobupivacaine, Drug: Ropivacaine, Drug: Mepivacaine, Drug: Tetracaine, Drug: Prilocaine, Drug: Procaine, Drug: Chloroprocaine, Drug: Benzocaine, Drug: ArticaineThe 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years and older
- Inpatients
- Scheduled for a non-cardiac surgical procedure under general or central neuraxial anesthesia
Key exclusion criteria (3 listed)
- Pre-existing end-stage renal disease: operationalized as a preoperative need for dialysis
- The following surgical procedures: renal surgery, cardiac surgery, organ transplantation, ophthalmic surgery, endoscopic gastrointestinal procedures, and (interventional) radiologic procedures.
- small non-invasive or minimally-invasive procedures will also be excluded, operationalized as excluding procedures with a surgical time of less than twenty minutes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Attending real-time decision supportNear real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia. | Procedure or surgery | Hypotension decision support |
| In-room real-time decision supportNear real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia. | Procedure or surgery | Hypotension decision support |
| Attending feedback emailsAttending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia. | Procedure or surgery | Hypotension decision support |
| In-room provider feedback emailsIn-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia. | Procedure or surgery | Hypotension decision support |
| Anesthesia Information Management System (AIMS)The anesthesia electronic record keeping system | Device | Hypotension decision support |
| Perioperative Data Warehouse (PDW)The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails. | Device | Hypotension decision support |
| General anesthesiaAny anesthetic drugs that are used to induce general anesthesia above the level of sedation. | Procedure or surgery | Hypotension decision support, Usual care group |
| Pager systemThe mobile pager system through which alerts can be sent | Device | Hypotension decision support |
| Central neuraxial anesthesiaAlso: Regional anesthesia, Spinal anesthesia, Intrathecal anesthesia, Subarachnoid anesthesiaRegional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia. | Procedure or surgery | Hypotension decision support, Usual care group |
| Non-cardiac surgeryAny surgical intervention that is not aimed at surgical correction of the heart | Procedure or surgery | Hypotension decision support, Usual care group |
| PropofolAnesthetic drug used to maintain general anesthesia | Drug | Hypotension decision support, Usual care group |
| SevofluraneAnesthetic drug used to maintain general anesthesia | Drug | Hypotension decision support, Usual care group |
| DesfluraneAnesthetic drug used to maintain general anesthesia | Drug | Hypotension decision support, Usual care group |
| IsofluraneAnesthetic drug used to maintain general anesthesia | Drug | Hypotension decision support, Usual care group |
| EphedrineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| PhenylephrineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| NorepinephrineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| EpinephrineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| DobutamineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| DopamineCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| IsoproterenolCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| MilrinoneCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| AtropineCardiovascular drugs used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| GlycopyrrolateCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| VasopressinCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| TerlipressinCardiovascular drug used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Sodium Chloride 0.9%Intravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Ringer's lactateIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Hydroxyethyl starch solutionsIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Fresh Frozen PlasmaIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Packed Red Blood CellsIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Albumin solutionsIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| Plasma-LyteIntravenous fluid used to treat intraoperative hypotension | Drug | Hypotension decision support, Usual care group |
| LidocaineAlso: LignocaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| BupivacaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| LevobupivacaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| RopivacaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| MepivacaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| TetracaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| PrilocaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| ProcaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| ChloroprocaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| BenzocaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
| ArticaineLocal anesthetic used for central neuraxial anesthesia. | Drug | Hypotension decision support, Usual care group |
Primary outcome
Postoperative Acute Kidney Injury
Time frame: Within 7 days after surgery
Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or >0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to > 4, or initiation of renal replacement therapy.
39 secondary outcomes
30-day Mortality
Time frame: 30 days after surgery
In-hospital Mortality
Time frame: All postoperative days during a single hospital admission, expected median of 5 days
Postoperative Acute Kidney Injury Stage 2
Time frame: Within 7 days after surgery
Postoperative Rise in Creatinine Levels
Time frame: Within 7 days after surgery
Incidence of a MAP < 60 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 60 mmHg for > 10 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg for > 10 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg for > 10 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 60 mmHg for > 20 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 55 mmHg for > 20 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Incidence of a MAP < 50 mmHg for > 20 Minutes
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Estimated Intraoperative Blood Loss
Time frame: During the surgical procedure: an expected average of 2 hours
Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
Time frame: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Ephedrine
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Phenylephrine
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Glycopyrrolate
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Epinephrine
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Average Use of Cardiovascular Drugs: Norepinephrine
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 65 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 60 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 55 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Timing of Cardiovascular Drugs for MAP < 50 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Intraoperative Administration of Intravenous Fluids
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Time frame: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Wanderer, MD, MPhil principal investigator
Vanderbilt University Medical Center, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attending real-time decision support, In-room real-time decision support and Attending feedback emails in people with Hypotension, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Acute Kidney Injury (time frame: Within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2019.