Norepinephrine vs Phenylephrine for Preventing Acute Kidney Injury
(VEGA-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two common medications, norepinephrine and phenylephrine, used to manage low blood pressure during major surgeries. The researchers aim to determine which medication better prevents kidney injury and other complications post-surgery. Hospitals across North America are testing these drugs, alternating between the two treatments each month. This trial suits adults undergoing surgeries lasting at least two hours under general anesthesia who require blood pressure medication during the procedure. Participants' data will be collected as part of their normal medical care, requiring no extra involvement from them. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on the use of specific blood pressure medications during surgery.
What is the safety track record for these treatments?
Research shows that norepinephrine and phenylephrine, the drugs studied in this trial, are commonly used during surgery to treat low blood pressure, though each carries safety concerns.
Studies have found that norepinephrine might increase the risk of kidney problems in patients with sepsis, a serious infection, and has been linked to higher death rates in some cases. While norepinephrine effectively raises blood pressure, it might cause kidney issues.
Phenylephrine has been associated with a higher risk of kidney injury during surgery. Specifically, one study found it increased the chance of acute kidney injury (AKI), a sudden drop in kidney function. This suggests that while phenylephrine helps manage low blood pressure, it might pose risks to the kidneys.
Both medications are generally well-tolerated, but understanding their potential risks can help patients make informed decisions about joining this trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments, norepinephrine and phenylephrine, because they offer different approaches to preventing acute kidney injury during general anesthesia. Norepinephrine is unique because it acts on both alpha and beta receptors, which can improve blood flow and potentially protect the kidneys more effectively. On the other hand, phenylephrine primarily targets alpha receptors, leading to increased blood pressure without affecting the heart rate much. This trial aims to determine whether the broader action of norepinephrine offers superior kidney protection compared to the more focused action of phenylephrine.
What evidence suggests that this trial's treatments could be effective for preventing acute kidney injury?
Research has shown that norepinephrine and phenylephrine are two common drugs used to treat low blood pressure during surgery. Norepinephrine narrows blood vessels and boosts heart function to raise blood pressure. However, studies have found that norepinephrine may increase the risk of kidney injury after surgery. Similarly, phenylephrine raises blood pressure by tightening blood vessels, but it has also been linked to a higher risk of kidney damage. Both drugs effectively raise blood pressure, but their effects on the kidneys are not fully understood, with some evidence suggesting possible risks. This trial will compare norepinephrine and phenylephrine to determine which drug might be safer for the kidneys during surgery. Participants will receive either norepinephrine or phenylephrine as the first-line intraoperative vasopressor during general anesthesia.56789
Who Is on the Research Team?
Sachin Kheterpal, MD MBA
Principal Investigator
University of Michigan
Matthieu Legrand, MD PhD
Principal Investigator
University of California, San Francisco
Allison Janda, MD
Principal Investigator
University of Michigan
Michael P Bokoch, MD PhD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for adults undergoing major noncardiac surgery lasting at least two hours under general anesthesia. It aims to see if certain medications can prevent kidney injury and other complications after surgery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either norepinephrine or phenylephrine as the first-line vasopressor during major non-cardiac surgery
Follow-up
Participants are monitored for acute kidney injury and other complications post-surgery
What Are the Treatments Tested in This Trial?
Interventions
- Norepinephrine
- Phenylephrine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
University of Michigan
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Washington
Collaborator
University of Virginia
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Wake Forest University Health Sciences
Collaborator
Henry Ford Health System
Collaborator
University of Maryland
Collaborator
Duke University
Collaborator