HypotensionNCT04062994
A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
An observational study of Hypotension and Acute Kidney Injury, run by University of California, Los Angeles at 4 sites in United States.
Trial summary
The purpose of this study is to provide messages to providers if their patient is at high risk of developing intraoperative hypotension based on past medical history and co-morbidities preoperatively and minutes of hypotension intraoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Acute Kidney Injury
- What is being tested?
- Nudge to reduce intraoperative hypotension
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 28 Sep 2018to 5 Oct 2019
- How long will I take part?
- 30 Days
- 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: All patients undergoing surgery at any of the UCLA operative locations
Who may be able to join
- All patients undergoing surgery at any of the UCLA operative locations
Who cannot join
- Patients less than age 18
- Patients undergoing cardiac surgery or liver transplantation
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jules Stein Eye Institute at UCLA
Los Angeles, California, 90095
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
UCLA Ambulatory Surgery Center
Los Angeles, California, 90095
UCLA Medical Center, Santa Monica
Santa Monica, California, 90404
About this study
The purpose of this study is to provide messages to providers if their patient is at high risk of developing intraoperative hypotension based on past medical history and co-morbidities preoperatively and minutes of hypotension intraoperatively.
Read the detailed description
Preoperative decision support:
Based on the patient's past medical history and comorbidities providers received one of two messages in the preoperative section of the chart. If the patient had a past medical history of renal insufficiency, congestive heart failure, or ischemic heart disease the provider received a message that the patient was at a high risk of developing sequale of hypotension. If the patient had more than 15 minutes of hypotension (defined as a mean arterial pressure (MAP)<65mmHg) during a previous anesthetic, then the provider received a message that the patient was at high risk of developing intraoperative hypotension. Based on the past medical history of the patient, providers will receive zero, one or both messages.
Intraoperative decision support:
In the vitals signs section of the intraoperative record a line denoting the mean arterial pressure (MAP) was added. If the patient had more than 10 cumulative minutes of hypotension (defined as a MAP<65 mmHg) then a yellow alert was displayed in the lower right section of the screen. If the patient had more than 20 minutes of hypotension, then the alert was changed to red.
Data Analysis:
All study data were acquired via our previously published Department of Anesthesiology and Perioperative Medicine at University of California, Los Angeles (UCLA) perioperative data ware- house (PDW). The PDW is a structured reporting schema that contains all the relevant clinical data entered into the electronic medical record (EMR) via the use of Clarity, the relational database created by EPIC for data analytics and reporting. While Clarity contains raw clinical data, the PDW was designed to organize, filter, and improve data so that it can be used reliably for creating these types of metrics. Last, the PDW servers interfaced with other health system resources to allow for automated emailed reports and the generation of web-based graphical dashboards.
Analysis of Hypotension:
For each case, hypotension was defined as the total number of minutes the patient spent with a blood pressure below predefined MAP mmHG thresholds (as previously reported Salmasi paper): 60-65, 55-60, 50-55, and <50. In order to determine the effect of the pathway roll out on the incidence of intraoperative hypotension the investigators plan to carry out several analyses.
- For each month from 12 months before pathway go-live until 12 months after go-live the percentage of case that experienced hypotension as defined above in the ranges of 0-10 minutes, 11-20 minutes, and >20 minutes (the cut-points used in the decision support system) will be computed.
- In essence patients were assigned to one of four pathways in the CDS program based on their risk of hypotension or sequalae of hypotension. The investigators will carry out sub-group analysis on each of the four pathways (hypotension message, high risk of complications message, both messages, no message) to see if the response of providers differed based on the message they received.
Analysis of the effect of decision support on postoperative AKI:
In order to determine the effect of the pathway to decrease postoperative AKI (defined by the KDIGO criteria as a binary instance 0 vs stage 1,2,3) the investigators carried out the following analysis
Patient characteristics (age, sex, ASA, etc…) and study variables (including hypotension, AKI) will be summarized using means (SD) and frequencies (%) stratified by pre/post intervention. The investigators will then create a risk score for postoperative AKI based upon the risk factors identified by Sun et al. For each patient in the post implementation group the investigators will identify a patient in the pre-implementation group who has a similar risk of AKI using propensity score matching in R V3.5.1 (Vienna, AU www.r-project.org ). The investigators will assess the performance of the matching algorithm by exploring standardized mean difference (SMD) plots before and after matching. If the matching is deemed to be inadequate (SMD > 0.1 for any matching variable) the investigators will try more complex models including squared terms, interactions, or widening the caliper width for what the investigators consider an adequate match (from the standard starting width of 0.2*SD of the logit of the propensity score). Once the matching has been deemed successful, the investigators will then assess the effect of the intervention by analyzing the incidence of hypotension in each month from the 12 months prior to roll until until the 12 months after roll out after allowing for a 2 month washout period using an interrupted time series approach as described by Wagner et. Al.
Since the effect of the intervention will likely have a negligible effect on low risk patients, the investigators will carry out a subgroup analysis on those patients at high risk of AKI and use methodology similar to those described above.
Finally, if the investigators observe a significant reduction in AKI according to the process outlined above, the investigators hypothesize that this reduction would be mediated through hypotension and test this using Baron and Kenny's steps for mediation:
- First, on the risk matched cohort, the investigators will show that the rate of AKI went down after implementation (a significant path C)
- Next, the investigators will show that the intervention is associated with a reduction in time spent in at least one hypotension category (60-65, 55-60, 50-55, <50) in a similar manner as above (significant path A)
- Finally, the investigators will show that the association between the intervention and AKI goes away (or is reduced) after including hypotension information in the model and use Sobel's test to obtain a p-value to test for a significant reduction in the intervention coefficient.
If any of these steps above fail (a,b,c) then the investigators cannot conclude that the reduction in AKI was mediated exclusively through hypotension.
- Conditions
- Hypotension, Acute Kidney Injury
- Being tested
- Nudge to reduce intraoperative hypotension
- Keywords
- Hypotension, AKI
- 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.
Nudge to reduce intraoperative hypotensionBehavioural
Providers will be alerted if their patients are at high risk of hypotension or at increased risk of sequelae from hypotension. Intraoperatively, if patients have more than 10 minutes of hypotension an alert will be displayed on the screen.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | All patients scheduled for surgery at a UCLA site in the one year period after go-live Receives: Behavioral: Nudge to reduce intraoperative hypotension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Risk adjusted rate of postoperative AKI
Measured: within 7 days post-surgery
Secondary outcomes (1)
Hypotension
The total number of minutes the patient spent with a blood pressure below predefined MAP mmHG thresholds: 60-65, 55-60, 50-55, and <50.
Measured: 1) For each month from 12 months before pathway go-live until 12 months after go-live.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start28 Sep 2018
- Primary completion5 Oct 2019
- Study completion5 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062994
- Sponsor's protocol ID
- Anes-Hypotension
- Status last verified
- Mar 2024
- First submitted
- 8 Aug 2019
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Decision Support Trial to Reduce Intraoperative Hypotension
- ClinicalTrials.gov ID
- NCT04062994
- Acronym / sponsor ID
- Anes-Hypotension
- Conditions
- Hypotension, Acute Kidney Injury
- Keywords
- Hypotension, AKI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30,000 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 5 Oct 2019 (actual)
- Study completion
- 5 Oct 2019 (actual)
- First posted
- 20 Aug 2019 (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 purpose of this study is to provide messages to providers if their patient is at high risk of developing intraoperative hypotension based on past medical history and co-morbidities preoperatively and minutes of hypotension intraoperatively.
Detailed description
Preoperative decision support:
Based on the patient's past medical history and comorbidities providers received one of two messages in the preoperative section of the chart. If the patient had a past medical history of renal insufficiency, congestive heart failure, or ischemic heart disease the provider received a message that the patient was at a high risk of developing sequale of hypotension. If the patient had more than 15 minutes of hypotension (defined as a mean arterial pressure (MAP)<65mmHg) during a previous anesthetic, then the provider received a message that the patient was at high risk of developing intraoperative hypotension. Based on the past medical history of the patient, providers will receive zero, one or both messages.
Intraoperative decision support:
In the vitals signs section of the intraoperative record a line denoting the mean arterial pressure (MAP) was added. If the patient had more than 10 cumulative minutes of hypotension (defined as a MAP<65 mmHg) then a yellow alert was displayed in the lower right section of the screen. If the patient had more than 20 minutes of hypotension, then the alert was changed to red.
Data Analysis:
All study data were acquired via our previously published Department of Anesthesiology and Perioperative Medicine at University of California, Los Angeles (UCLA) perioperative data ware- house (PDW). The PDW is a structured reporting schema that contains all the relevant clinical data entered into the electronic medical record (EMR) via the use of Clarity, the relational database created by EPIC for data analytics and reporting. While Clarity contains raw clinical data, the PDW was designed to organize, filter, and improve data so that it can be used reliably for creating these types of metrics. Last, the PDW servers interfaced with other health system resources to allow for automated emailed reports and the generation of web-based graphical dashboards.
Analysis of Hypotension:
For each case, hypotension was defined as the total number of minutes the patient spent with a blood pressure below predefined MAP mmHG thresholds (as previously reported Salmasi paper): 60-65, 55-60, 50-55, and <50. In order to determine the effect of the pathway roll out on the incidence of intraoperative hypotension the investigators plan to carry out several analyses.
- For each month from 12 months before pathway go-live until 12 months after go-live the percentage of case that experienced hypotension as defined above in the ranges of 0-10 minutes, 11-20 minutes, and >20 minutes (the cut-points used in the decision support system) will be computed.
- In essence patients were assigned to one of four pathways in the CDS program based on their risk of hypotension or sequalae of hypotension. The investigators will carry out sub-group analysis on each of the four pathways (hypotension message, high risk of complications message, both messages, no message) to see if the response of providers differed based on the message they received.
Analysis of the effect of decision support on postoperative AKI:
In order to determine the effect of the pathway to decrease postoperative AKI (defined by the KDIGO criteria as a binary instance 0 vs stage 1,2,3) the investigators carried out the following analysis
Patient characteristics (age, sex, ASA, etc…) and study variables (including hypotension, AKI) will be summarized using means (SD) and frequencies (%) stratified by pre/post intervention. The investigators will then create a risk score for postoperative AKI based upon the risk factors identified by Sun et al. For each patient in the post implementation group the investigators will identify a patient in the pre-implementation group who has a similar risk of AKI using propensity score matching in R V3.5.1 (Vienna, AU www.r-project.org ). The investigators will assess the performance of the matching algorithm by exploring standardized mean difference (SMD) plots before and after matching. If the matching is deemed to be inadequate (SMD > 0.1 for any matching variable) the investigators will try more complex models including squared terms, interactions, or widening the caliper width for what the investigators consider an adequate match (from the standard starting width of 0.2*SD of the logit of the propensity score). Once the matching has been deemed successful, the investigators will then assess the effect of the intervention by analyzing the incidence of hypotension in each month from the 12 months prior to roll until until the 12 months after roll out after allowing for a 2 month washout period using an interrupted time series approach as described by Wagner et. Al.
Since the effect of the intervention will likely have a negligible effect on low risk patients, the investigators will carry out a subgroup analysis on those patients at high risk of AKI and use methodology similar to those described above.
Finally, if the investigators observe a significant reduction in AKI according to the process outlined above, the investigators hypothesize that this reduction would be mediated through hypotension and test this using Baron and Kenny's steps for mediation:
- First, on the risk matched cohort, the investigators will show that the rate of AKI went down after implementation (a significant path C)
- Next, the investigators will show that the intervention is associated with a reduction in time spent in at least one hypotension category (60-65, 55-60, 50-55, <50) in a similar manner as above (significant path A)
- Finally, the investigators will show that the association between the intervention and AKI goes away (or is reduced) after including hypotension information in the model and use Sobel's test to obtain a p-value to test for a significant reduction in the intervention coefficient.
If any of these steps above fail (a,b,c) then the investigators cannot conclude that the reduction in AKI was mediated exclusively through hypotension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Behavioral: Nudge to reduce intraoperative hypotensionAll patients scheduled for surgery at a UCLA site in the one year period after go-live |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery at any of the UCLA operative locations
Key inclusion criteria (1 listed)
- All patients undergoing surgery at any of the UCLA operative locations
Key exclusion criteria (2 listed)
- Patients less than age 18
- Patients undergoing cardiac surgery or liver transplantation
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 |
|---|---|---|
| Nudge to reduce intraoperative hypotensionProviders will be alerted if their patients are at high risk of hypotension or at increased risk of sequelae from hypotension. Intraoperatively, if patients have more than 10 minutes of hypotension an alert will be displayed on the screen. | Behavioural | Intervention Group |
Primary outcome
Acute Kidney Injury (AKI)
Time frame: within 7 days post-surgery
Risk adjusted rate of postoperative AKI
1 secondary outcome
Hypotension
Time frame: 1) For each month from 12 months before pathway go-live until 12 months after go-live.
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 6 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Acute Kidney Injury, run by University of California, Los Angeles at 4 sites 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 1 inclusion and 2 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 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Acute Kidney Injury (AKI) (time frame: within 7 days post-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 6 Mar 2024.