Comparing Norepinephrine and Phenylephrine to Prevent Kidney Injury After Major Non-Cardiac Surgery Under General Anesthesia
Led by University of California, San Francisco · Updated on 2026-05-26
18000
Participants Needed
10
Research Sites
N/A
Total Duration
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
Research Team
M
Matthieu Legrand, MD PhD
M
Michael P. Bokoch, MD PhD
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
How This Trial Compares With Other Options
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Norepinephrine
Phenylephrine
What it is
Norepinephrine is a vasopressor drug delivered by intravenous infusion or bolus to increase blood pressure during surgery.
Phenylephrine is a vasopressor drug given intravenously to treat low blood pressure during surgery.
Role in the trial
Tested as one approach to manage low blood pressure during major non-cardiac surgery. Administered to eligible participants in the randomized crossover trial.
Tested as an alternative strategy to support blood pressure in the same population. Also provided to participants through random assignment.
Primary use
Maintaining blood pressure within a target range during surgery to help reduce risk of organ injury, such as acute kidney injury.
Used to support blood pressure during the surgical procedure, aiming to prevent intraoperative hypotension and related complications.
How it is given or performed
Intravenous infusion and/or bolus doses during general anesthesia, dosed according to patient need and surgical events.
Given intravenously as either a continuous infusion or in bolus doses, depending on surgical blood pressure needs.
Evidence status
Extensively used in surgical anesthesia, with growing evidence from randomized and observational studies about its effects on blood pressure, organ protection, and kidney function.
Has a long history of clinical use and is considered a reference vasopressor for managing low blood pressure during anesthesia. Clinical evidence continues to evaluate its impact on patient outcomes.
Important limitations
Optimal choice between vasopressors and their effect on major organ outcomes in surgery remains under study. Larger, definitive trials are ongoing to establish effect on kidney health after surgery.
Potential differences in organ protection, such as kidney health or heart risk, are not fully established; expert reviews note the need for more high-quality studies comparing vasopressors in surgery.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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
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
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
Norepinephrine 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.
Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial.
Relationship 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.