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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

  1. 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.
  2. 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:

  1. First, on the risk matched cohort, the investigators will show that the rate of AKI went down after implementation (a significant path C)
  2. 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)
  3. 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.

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 groups in NCT04062994
Study groupRoleWhat they receive
Intervention GroupAll 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.

  1. Acute Kidney Injury (AKI)

    Risk adjusted rate of postoperative AKI

    Measured: within 7 days post-surgery

Secondary outcomes (1)
  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.

  1. First posted20 Aug 2019
  2. Study start28 Sep 2018
  3. Primary completion5 Oct 2019
  4. Study completion5 Oct 2019

Resources

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
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

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.

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