The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
Recruiting now · Phase 4
Conditions studied: Anesthesia, Surgery With General Anesthesia, Noncardiac Surgery, Hypotension During Surgery, Acute Kidney Injury (AKI), Myocardial Injury After Noncardiac Surgery (MINS), Vasopressor
In brief
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.
Key facts
- Study ID
- NCT06802224
- Run by
- University of California, San Francisco
- People needed
- 18000
- Starts
- 2025-04-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Surgery under general anesthesia with a surgery duration of 2 hours or more
- Received intravenous vasopressors during surgery
You may not qualify if…
- 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
Where it is running
- University of California, San Francisco — San Francisco, California, United States (enrolling)
- University of Maryland — College Park, Maryland, United States (enrolling)
- University of Michigan — Ann Arbor, Michigan, United States (enrolling)
- Henry Ford Health — Detroit, Michigan, United States (enrolling)
- Duke University Medical Center — Durham, North Carolina, United States (enrolling)
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States (enrolling)
- UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- University of Washington — Seattle, Washington, United States (enrolling)
- University Health Network — Toronto, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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