Recruiting

Vasopressor

Sponsor:

UCLA

Code:

NCT06802224

Conditions

Anesthesia

Surgery With General Anesthesia

Noncardiac Surgery

Hypotension During Surgery

Acute Kidney Injury (AKI)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Norepinephrine

Phenylephrine

Study Details

Brief 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)

Study ID

NCT06802224

Start date

Apr 1, 2025

Status verified date

May, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Surgery under general anesthesia with a surgery duration of 2 hours or more
  • Received intravenous vasopressors during surgery

Exclusion Criteria:

  • Cardiac surgery
  • Extra-corporeal membrane oxygenation
  • Organ transplantation
  • Obstetric procedures
  • Procedures on the kidney
  • Outpatient procedures
  • Already receiving NE or PE or inotropes before induction of anesthesia (at the time of anesthesia start)
  • American Society of Anesthesiologists physical status classification 5 or 6
  • Patient for whom a local protocol recommends a specific first line vasopressor
  • Most recent documented estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m\^2 or preoperative renal replacement therapy within 60 days before surgery
  • Patients who do not have a preoperative creatinine value within 60 days before surgery
  • Alive patients who do not have a postoperative creatinine value

Study Design

Enrollment

18000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Norepinephrine

Intravenous Norepinephrine for both infusion and bolus dosing

Phenylephrine

Intravenous Phenylephrine for both infusion and bolus dosing

Primary outcome measure

  • Acute Kidney Injury (AKI) [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Michael P Bokoch, MD PhD

415-476-8389michael.bokoch@ucsf.edu

Elisia Leung, BA

Elisia.Leung@ucsf.edu

Principal Investigator:

Matthieu Legrand, MD PhD

University of Maryland

Recruiting

College Park, Maryland, United States, 20742

Contacts

Principal Investigator:

Megan Anders, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Sachin Kheterpal, MD, MBA

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Katherine A Nowak, PhD

KNowak2@hfhs.org

Principal Investigator:

Mousab M Eteer, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Michael Manning, MD

Wake Forest University School of Medicine

Recruiting

Winston-Salem, North Carolina, United States, 27101

Contacts

Principal Investigator:

Ashish Khanna, MD

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Siddharth Dave, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Bhiken Naik, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Karen B Domino, MD

kdomino@uw.edu

Principal Investigator:

Karen B Domino, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Principal Investigator:

Tariq Esmail, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Norepinephrine
  • Phenylephrine
  • Major adverse kidney events
  • Pragmatic
  • Cluster randomized
  • Crossover

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-05-26.