About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Surgery under general anesthesia with a surgery duration of 2 hours or more
Received intravenous vasopressors during surgery
Disqualifiers
Cardiac surgery
Extra-corporeal membrane oxygenation
Organ transplantation
Obstetric procedures
Trial design
Crossover
Treatments tested in this trial
Norepinephrine
DrugIntravenous Norepinephrine for both infusion and bolus dosing
Phenylephrine
DrugIntravenous Phenylephrine for both infusion and bolus dosing
Treatment groups
Trial outcomes
Primary outcomes
Acute Kidney Injury (AKI)
AKI will be defined by the change of serum creatinine based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.
Secondary outcomes
Major Adverse Kidney Events (MAKE)
The composite of severe AKI (i.e. stage 2 or 3 AKI based on the KDIGO creatinine-based definition), absence of renal recovery, and/or death.
Other outcomes
Myocardial Injury after Noncardiac Surgery (MINS)
Elevated cardiac normal or high-sensitivity troponin.
Hospital length of stay
Number of days of inpatient admission.
Hypotension
Mean arterial pressure less than 65 mmHg for at least 15 cumulative minutes.
Duration of hypotension
The cumulative number of minutes with mean arterial pressure less than 65 mmHg.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Michigan
Collaborator
Henry Ford Health System
Collaborator
University of Washington
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Wake Forest University Health Sciences
Collaborator
University of Virginia
Collaborator
University of Maryland
Collaborator
Duke University
Collaborator
University Health Network, Toronto
Collaborator