NCT04062994

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 28, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

August 8, 2019

Last Update Submit

March 4, 2024

Conditions

HypotensionAcute Kidney Injury

Keywords

HypotensionAKI

Outcome Measures

Primary Outcomes (1)

  • Acute Kidney Injury (AKI)

    Risk adjusted rate of postoperative AKI

    within 7 days post-surgery

Secondary Outcomes (1)

  • Hypotension

    1) For each month from 12 months before pathway go-live until 12 months after go-live.

Study Arms (1)

Intervention Group

All patients scheduled for surgery at a UCLA site in the one year period after go-live

Behavioral: Nudge to reduce intraoperative hypotension

Interventions

Nudge to reduce intraoperative hypotensionBEHAVIORAL

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing surgery at any of the UCLA operative locations

You may qualify if:

  • \- All patients undergoing surgery at any of the UCLA operative locations

You may not qualify if:

  • Patients less than age 18
  • Patients undergoing cardiac surgery or liver transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Jules Stein Eye Institute at UCLA

Los Angeles, California, 90095, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

UCLA Ambulatory Surgery Center

Los Angeles, California, 90095, United States

Location

UCLA Medical Center, Santa Monica

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

HypotensionAcute Kidney Injury

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

August 20, 2019

Study Start

September 28, 2018

Primary Completion

October 5, 2019

Study Completion

October 5, 2019

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)