Hypotension During SurgeryNCT04803903
HPI Index With GDHT in Predicting Hypotension In General Anesthesia Patients
An observational study of Hypotension During Surgery, run by Attikon Hospital at 1 site in Greece.
Trial summary
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- Flotraq Sensor with EV1000 incorporating the HPI algorithm
- Type of treatment
- Medical device
- How many people
- 99 participants
- Where
- 1 siteGreece
- Study dates
- 5 Nov 2018to 20 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We selected adults (age 18 years or older), that underwent surgery lasting for more that 2 hours in which an arterial line was deemed necessary for their hemodynamic monitoring and treatment
Who may be able to join
- Aged 18 years or older
- Planned to receive general anaesthesia > 2h
- Planned to receive an arterial line during surgery
- Aim for MAP of ≥ 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
Who cannot join
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
- Severe cardiac arrhythmias including atrial fibrillation
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- Requiring dialysis
- Liver surgery with Pringle maneuver
- Vascular surgery with clamping of the aorta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In General Anesthesia Patients?
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.
Read the detailed description
The perioperative period is characterized by hemodynamic instability. Intraoperative hypotension (IOH) can be caused by anesthesia drugs, surgical manipulations, hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms. In a retrospective analysis performed at the Cleveland Clinic, the risk for acute kidney injury (AKI) and myocardial injury (MI) increased when mean arterial pressure (MAP) was less than 55 mmHg. Further, even short durations of intraoperative hypotension were associated with AKI and MI. Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure. They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and ΜΙ or ΑΚΙ at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with ΜΙ or ΑΚΙ from those without it. The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure. In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min.
Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse, followed by prompt treatment and, ultimately, reversal of the responsible process. Recently a Hypotension Probability Indicator (HPI) algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. The HPI algorithm can be integrated with a goal-directed hemodynamic treatment (GDHT) to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure. We developed a treatment protocol implementing HPI with GDHT that can be used in general anesthesia patients to guide clinical practice.
- Conditions
- Hypotension During Surgery
- Being tested
- Flotraq Sensor with EV1000 incorporating the HPI algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flotraq Sensor with EV1000 incorporating the HPI algorithmDevice
The HPI algorithm is only available on the EV1000, Hemosphere and Flotrac monitoring systems and requires the use of a Flotrac sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The Flotrac sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study).
In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart . If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immedietaly. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere/EV1000 with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension.
| Study group | Role | What they receive |
|---|---|---|
| HPI + GDHT treatment | HPI + GDHT treatment using the FlowTraQ sensor and EV1000 monitor with the HPI algorithm incorporated following our protocol for hemodynamic treatment (fluids, vasopressors and inotropes) administered Receives: Device: Flotraq Sensor with EV1000 incorporating the HPI algorithm | |
| Control | Conventional treatment with invasive blood pressure monitoring. Administration of fluids and/or vasopressors are guided by standard hemodynamic parameters at the discretion of the attending physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
TWA hypotension (measured with Flotrac sensor)
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Secondary outcomes (9)
Incidence of hypotension (measured with Flotrac sensor)
Incidence of hypotension, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with Flotrac sensor)
Time spent in hypotension, in minutes, defined as MAP <65mmHg for ≥1min
Measured: intraoperative, starting 15 minutes after induction
Treatment choice (drugs/fluids)
Medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Measured: intraoperative, starting 15 minutes after induction
Treatment dose (drugs/fluids)
Dose of medication used to prevent/treat hypotension. A study member is present at the OR to make notes
Measured: intraoperative, starting 15 minutes after induction
Time to treatment (drugs/fluids)
time to treatment of hypotension, defined as MAP <65mmHg for ≥1min.
Measured: intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations
Diagnostic guidance protocol deviations, a study member is present at the OR to make notes of any protocol deviations.
Measured: intraoperative, starting 15 minutes after induction
Postoperative Morbidity
Incidence of complications: cardiac, pulmonary, renal
Measured: postoperative, up to 30 days after surgery or until discharge from the hospital
Postoperative Creatinine levels
Measurement if creatinine levels postoperatively
Measured: postoperative, up to 30 days after surgery or until discharge from the hospital
Mortality
Incidence of mortality 30 days after surgery
Measured: postoperative, up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start5 Nov 2018
- Primary completion30 Mar 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiana Sidiropoulou, Attikon Hospital
- Investigators
- Tatiana Sidiropoulou, Principal investigator, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803903
- Sponsor's protocol ID
- 11.15.2018
- Status last verified
- Jul 2021
- First submitted
- 15 Mar 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share protocol for hemodynamic treatment based on the HPI algorith as well as raw data
Publications
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
PubMed 27792044Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
PubMed 26181335
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In General Anesthesia Patients?
- ClinicalTrials.gov ID
- NCT04803903
- Acronym / sponsor ID
- 11.15.2018
- Conditions
- Hypotension During Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.
Detailed description
The perioperative period is characterized by hemodynamic instability. Intraoperative hypotension (IOH) can be caused by anesthesia drugs, surgical manipulations, hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms. In a retrospective analysis performed at the Cleveland Clinic, the risk for acute kidney injury (AKI) and myocardial injury (MI) increased when mean arterial pressure (MAP) was less than 55 mmHg. Further, even short durations of intraoperative hypotension were associated with AKI and MI. Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure. They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and ΜΙ or ΑΚΙ at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with ΜΙ or ΑΚΙ from those without it. The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure. In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min.
Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse, followed by prompt treatment and, ultimately, reversal of the responsible process. Recently a Hypotension Probability Indicator (HPI) algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. The HPI algorithm can be integrated with a goal-directed hemodynamic treatment (GDHT) to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure. We developed a treatment protocol implementing HPI with GDHT that can be used in general anesthesia patients to guide clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HPI + GDHT treatment | – | Device: Flotraq Sensor with EV1000 incorporating the HPI algorithmHPI + GDHT treatment using the FlowTraQ sensor and EV1000 monitor with the HPI algorithm incorporated following our protocol for hemodynamic treatment (fluids, vasopressors and inotropes) administered |
| Control | – | –Conventional treatment with invasive blood pressure monitoring. Administration of fluids and/or vasopressors are guided by standard hemodynamic parameters at the discretion of the attending physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We selected adults (age 18 years or older), that underwent surgery lasting for more that 2 hours in which an arterial line was deemed necessary for their hemodynamic monitoring and treatment
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Planned to receive general anaesthesia > 2h
- Planned to receive an arterial line during surgery
- Aim for MAP of ≥ 65 mmHg during surgery
- Being able to give written informed consent prior to surgery
Key exclusion criteria (9 listed)
- Aim for MAP other than 65 mmHg at discretion treating physician
- Significant hypotension before surgery defined as a MAP <65
- Right- or left sided cardiac failure (e.g. LVEF<35%)
- Known cardiac shunts (significant)
- Known aortic stenosis (severe)
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 |
|---|---|---|
| Flotraq Sensor with EV1000 incorporating the HPI algorithmThe HPI algorithm is only available on the EV1000, Hemosphere and Flotrac monitoring systems and requires the use of a Flotrac sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The Flotrac sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study). In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart . If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immedietaly. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere/EV1000 with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension. | Device | HPI + GDHT treatment |
Primary outcome
TWA hypotension (measured with Flotrac sensor)
Time frame: intraoperative, starting 15 minutes after induction
Time weighted average spent in hypotension, defined as MAP <65mmHg for ≥1min
9 secondary outcomes
Incidence of hypotension (measured with Flotrac sensor)
Time frame: intraoperative, starting 15 minutes after induction
Time spent in hypotension (measured with Flotrac sensor)
Time frame: intraoperative, starting 15 minutes after induction
Treatment choice (drugs/fluids)
Time frame: intraoperative, starting 15 minutes after induction
Treatment dose (drugs/fluids)
Time frame: intraoperative, starting 15 minutes after induction
Time to treatment (drugs/fluids)
Time frame: intraoperative, starting 15 minutes after induction
Diagnostic guidance protocol deviations
Time frame: intraoperative, starting 15 minutes after induction
Postoperative Morbidity
Time frame: postoperative, up to 30 days after surgery or until discharge from the hospital
Postoperative Creatinine levels
Time frame: postoperative, up to 30 days after surgery or until discharge from the hospital
Mortality
Time frame: postoperative, up to 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Background: PubMed 27792044Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
- Background: PubMed 26181335Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
- Individual participant dataSharing planned: Yes. We will share protocol for hemodynamic treatment based on the HPI algorith as well as raw data
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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.
Tatiana Sidiropoulou principal investigator
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension During Surgery, run by Attikon Hospital at 1 site in Greece.
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 5 inclusion and 9 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 30 Jul 2021. 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 Greece. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TWA hypotension (measured with Flotrac sensor) (time frame: intraoperative, starting 15 minutes after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803903, which also lists 3 linked publications.
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 30 Jul 2021.