The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Norepinephrine

    Drug

    Intravenous Norepinephrine for both infusion and bolus dosing

  • Phenylephrine

    Drug

    Intravenous Phenylephrine for both infusion and bolus dosing

Treatment groups

18,000 Participants
are divided into 2 treatment groups
Group A: NorepinephrineActive comparator 1 intervention
Group B: PhenylephrineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Acute Kidney Injury (AKI)

AKI will be defined by the change of serum creatinine based on the Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Time frame
7 days

Secondary outcomes

1

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.

Time frame
28 days

Other outcomes

1

Myocardial Injury after Noncardiac Surgery (MINS)

Elevated cardiac normal or high-sensitivity troponin.

Time frame
28 days
2

Hospital length of stay

Number of days of inpatient admission.

Time frame
28 days
3

Hypotension

Mean arterial pressure less than 65 mmHg for at least 15 cumulative minutes.

Time frame
During anesthesia care
4

Duration of hypotension

The cumulative number of minutes with mean arterial pressure less than 65 mmHg.

Time frame
During anesthesia care

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