Fluids, vasopressors, and acute kidney injury after major abdominal surgery between 2015 and 2019: a multicentre retrospective analysis.
Catherine Chiu, Nicholas Fong, Daniel Lazzareschi...
https://pubmed.ncbi.nlm.nih.gov/35688657Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID06802224
Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery
Led by University of California, San Francisco · Updated on 2026-05-26
18000
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating which vasopressor medication, norepinephrine or phenylephrine, is better at preventing kidney injury and other complications such as heart problems in adults undergoing major noncardiac surgery lasting at least two hours under general anesthesia. Low blood pressure during such surgeries is common and can lead to slower recovery due to kidney injury. This trial is a phase 4, cluster-randomized study conducted across multiple hospitals in North America to compare these two standard medications. In this open-label trial, hospital centers will alternate monthly between using either norepinephrine or phenylephrine as the primary intravenous vasopressor to treat low blood pressure during surgery. Anesthesia providers will administer these drugs by infusion or bolus dosing, adjusting doses to maintain target blood pressure. Providers may use the alternative vasopressor if clinically indicated, and standard care will be provided throughout. Data will be collected automatically from routine electronic health records without extra procedures or tests. Participants' involvement requires no additional visits or tests beyond usual care. Researchers will collect de-identified data on kidney function and other outcomes from medical records, focusing on acute kidney injury within 7 days after surgery and major kidney events within 28 days. The trial will continue until about 2028, monitoring these outcomes to determine which vasopressor better supports patient recovery after major surgery.
CONDITIONS
Brief Title
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Undergoing surgery under general anesthesia lasting 2 hours or more
- Receiving intravenous vasopressor medications during surgery
You will not qualify if you...
- Undergoing cardiac surgery
- Receiving extra-corporeal membrane oxygenation
- Having organ transplantation
- Undergoing obstetric procedures
- Having procedures on the kidney
- Outpatient procedures
- Receiving norepinephrine, phenylephrine, or inotropes before anesthesia starts
- American Society of Anesthesiologists physical status classification 5 or 6
- Having a local protocol recommending a specific first line vasopressor
- Estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73m² or preoperative renal replacement therapy within 60 days before surgery
- No preoperative creatinine value within 60 days before surgery
- Alive patients without a postoperative creatinine value
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of surgery (2 hours or more)
Participants receive either norepinephrine or phenylephrine as the first-line vasopressor during general anesthesia to manage blood pressure during surgery.
1 intraoperative treatment period
Follow-up
Duration - 28 days
Participants are monitored for kidney function and adverse events following surgery.
Follow-up assessments as per routine clinical care
Trial Site Locations
Total: 10 locations
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
2
University of Maryland
College Park, Maryland, United States, 20742
Actively Recruiting
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
5
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
6
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27101
Actively Recruiting
7
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
8
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
9
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
10
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
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Research Team
M
Matthieu Legrand, MD PhD
M
Michael P. Bokoch, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.
Emmanuel Futier, Jean-Yves Lefrant, Pierre-Gregoire Guinot...
https://pubmed.ncbi.nlm.nih.gov/28973220Risk of Major Complications After Perioperative Norepinephrine Infusion Through Peripheral Intravenous Lines in a Multicenter Study.
Carlo Pancaro, Nirav Shah, Wietze Pasma...
https://pubmed.ncbi.nlm.nih.gov/32925324Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative.
John R Prowle, Lui G Forni, Max Bell...
https://pubmed.ncbi.nlm.nih.gov/33976395Should Norepinephrine, Rather than Phenylephrine, Be Considered the Primary Vasopressor in Anesthetic Practice?
Berend Mets
https://pubmed.ncbi.nlm.nih.gov/27101504Ten tips to optimize vasopressors use in the critically ill patient with hypotension.
Matthieu Legrand, Alexander Zarbock
https://pubmed.ncbi.nlm.nih.gov/35504977Preoperative Risk and the Association between Hypotension and Postoperative Acute Kidney Injury.
Michael R Mathis, Bhiken I Naik, Robert E Freundlich...
https://pubmed.ncbi.nlm.nih.gov/31794513Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis.
Vafi Salmasi, Kamal Maheshwari, Dongsheng Yang...
https://pubmed.ncbi.nlm.nih.gov/27792044Norepinephrine versus phenylephrine for treating hypotension during general anaesthesia in adult patients undergoing major noncardiac surgery: a multicentre, open-label, cluster-randomised, crossover, feasibility, and pilot trial.
Matthieu Legrand, Rishi Kothari, Nicholas Fong...
https://pubmed.ncbi.nlm.nih.gov/36925330