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

Summary

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

• Anesthesia
• Surgery With General Anesthesia
• Noncardiac Surgery
• Hypotension During Surgery
• Acute Kidney Injury (AKI)
• Myocardial Injury After Noncardiac Surgery (MINS)
• Vasopressor

Interventions

DRUG

Norepinephrine

Intravenous Norepinephrine for both infusion and bolus dosing

DRUG

Phenylephrine

Intravenous Phenylephrine for both infusion and bolus dosing

Sponsors & Collaborators

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

  collaborator NIH

• University of Michigan

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Texas Southwestern Medical Center

  collaborator OTHER

• Wake Forest University Health Sciences

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• University of Maryland

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Sachin Kheterpal, MD MBA · University of Michigan

• Matthieu Legrand, MD PhD · University of California, San Francisco

• Allison Janda, MD · University of Michigan

• Michael P Bokoch, MD PhD · University of California, San Francisco

• Douglas Colquhoun, MB ChB, MSc, MPH · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2028-07-31

Completion

2028-07-31

FDA Drug

Yes

Countries

• United States

Study Locations