RecruitingPhase 4NCT06802224

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

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


Sponsor

University of California, San Francisco

Enrollment

18,000 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria12

  • 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

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Interventions

DRUGNorepinephrine

Intravenous Norepinephrine for both infusion and bolus dosing

DRUGPhenylephrine

Intravenous Phenylephrine for both infusion and bolus dosing


Locations(8)

University of California, San Francisco

San Francisco, California, United States

University of Maryland

College Park, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

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NCT06802224


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