Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06802224

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Led by University of California, San Francisco · Updated on 2026-03-12

18000

Participants Needed

8

Research Sites

169 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Low blood pressure, also known as hypotension, is very common during major surgery under general anesthesia. Prolonged or severe hypotension can lead to complications such as kidney injury after surgery that slow down patient recovery. Anesthesiologists commonly administer medications called vasopressors to treat low blood pressure during surgery. These medications help raise the blood pressure back up to a safe range. Two vasopressor medications are commonly used for this purpose: norepinephrine and phenylephrine. Each of these medications has slightly different effects on the heart and blood vessels (cardiovascular system). It remains unknown which of these standard medications is better for treating low blood pressure during surgery. The goal of this clinical trial is to determine which of these two medications is better at preventing injury to the kidneys after major noncardiac surgery as well as other complications such as heart problems. Major surgeries are defined as those lasting at least two hours under general anesthesia. This trial will randomize about ten centers in North America to use either norepinephrine or phenylephrine as the primary medication to treat low blood pressure in adults undergoing major noncardiac surgery. Each hospital will prioritize one of the drugs each month, and the assigned drug will rotate each month at each hospital. No further participant involvement will be required as de-identified data are collected as part of standard medical care.

CONDITIONS

Official Title

The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Undergoing surgery under general anesthesia lasting 2 hours or more
  • Received intravenous vasopressors during surgery
Not Eligible

You will not qualify if you...

  • Undergoing cardiac surgery
  • Receiving extra-corporeal membrane oxygenation
  • Undergoing organ transplantation
  • Having obstetric procedures
  • Procedures involving the kidney
  • Outpatient procedures
  • Receiving norepinephrine, phenylephrine, or inotropes before anesthesia induction
  • American Society of Anesthesiologists physical status classification 5 or 6
  • Local protocol recommends a specific first-line vasopressor for the patient
  • Estimated glomerular filtration rate less than 15 mL/min/1.73m² or renal replacement therapy within 60 days before surgery
  • No preoperative creatinine value within 60 days before surgery
  • Alive patients without postoperative creatinine value

AI-Screening

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Trial Site Locations

Total: 8 locations

1

University of California, San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

2

University of Maryland

College Park, Maryland, United States, 20742

Actively Recruiting

3

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

4

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

5

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

6

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States, 27101

Actively Recruiting

7

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

8

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

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Research Team

M

Matthieu Legrand, MD PhD

CONTACT

M

Michael P. Bokoch, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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