Comparing two medications to prevent kidney injury after major surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to determine which vasopressor medication, norepinephrine or phenylephrine, is more effective in preventing acute kidney injury following major non-cardiac surgery. It employs a pragmatic, cluster-randomized, crossover design across multiple hospitals, where centers will alternate between using each medication based on the month. Data will be collected from routine clinical care without additional lab tests, focusing on the impact of these medications on patient outcomes during surgery. The study will involve patients aged 18 and older who require intravenous vasopressors during surgery lasting two hours or more.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Maryland
  College Park, Maryland, United States Recruiting
• University of Michigan
  Ann Arbor, Michigan, United States Recruiting
• Henry Ford Health
  Detroit, Michigan, United States Recruiting
• Duke University Medical Center
  Durham, North Carolina, United States Recruiting
• Wake Forest University School of Medicine
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Sachin Kheterpal, MD MBA — University of Michigan
• Study coordinator: Matthieu Legrand, MD PhD
• Email: matthieu.legrand@ucsf.edu
• Phone: 415-476-9035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.