Comparing two medications to prevent kidney injury after major surgery
Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery
This study is testing which medication, norepinephrine or phenylephrine, works better to prevent kidney injury in adults having major surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 18000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 8 sites (San Francisco, California and 7 other locations) |
| Trial ID | NCT06802224 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older undergoing major non-cardiac surgery lasting two hours or more who require intravenous vasopressors.
Not a fit: Patients undergoing cardiac surgery, organ transplantation, or those with severe pre-existing kidney conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved kidney health and recovery outcomes for patients undergoing major surgery.
How similar studies have performed: Other studies have explored the use of vasopressors in surgical settings, but this specific comparison of norepinephrine and phenylephrine is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Francisco, California and 7 other locations
- 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)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.