Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years or older

• Surgery under general anesthesia with a surgery duration of 2 hours or more

• Received intravenous vasopressors during surgery

Locations
United States
California
University of California, San Francisco
RECRUITING
San Francisco
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Matthieu Legrand, MD PhD
matthieu.legrand@ucsf.edu
415-476-9035
Backup
Michael P. Bokoch, MD PhD
michael.bokoch@ucsf.edu
415-476-8389
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2028-07
Participants
Target number of participants: 18000
Treatments
Active_comparator: Norepinephrine
Norepinephrine as the first-line intraoperative vasopressor during general anesthesia.
Active_comparator: Phenylephrine
Phenylephrine as the first-line intraoperative vasopressor during general anesthesia
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Washington, Wake Forest University Health Sciences, University of Michigan, University of Maryland, University of Virginia, Duke University, Henry Ford Health System, University of Texas Southwestern Medical Center
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov