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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06802224
Phase
PHASE4
Status
Recruiting
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Conditions

  • Acute Kidney Injury (AKI)
  • Anesthesia
  • Hypotension During Surgery
  • Myocardial Injury After Noncardiac Surgery (MINS)
  • Noncardiac Surgery
  • Surgery With General Anesthesia
  • Vasopressor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Norepinephrine — DRUG
    Intravenous Norepinephrine for both infusion and bolus dosing
  • Phenylephrine — DRUG
    Intravenous Phenylephrine for both infusion and bolus dosing

Study Details

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.

Key Dates

Start date
Apr 1, 2025
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
18,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Norepinephrine
    Norepinephrine as the first-line intraoperative vasopressor during general anesthesia.
  • Active Comparator: Phenylephrine
    Phenylephrine as the first-line intraoperative vasopressor during general anesthesia

Primary Outcome Measure

Acute Kidney Injury (AKI) [ Time Frame: 7 days ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Michael P Bokoch, MD PhD
[email protected]
415-476-8389
Elisia Leung, BA
[email protected]
Michael P Bokoch, MD PhD (SUB_INVESTIGATOR)
Matthieu Legrand, MD PhD (PRINCIPAL_INVESTIGATOR)
University of MarylandCollege ParkMaryland20742
Megan Anders, MD
[email protected]
410-328-4213
LaToya Stubbs
[email protected]
Megan Anders, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Allison Janda, MD
[email protected]
734-936-4000
Rebecca Pantis
[email protected]
Sachin Kheterpal, MD, MBA (PRINCIPAL_INVESTIGATOR)
Allison Janda, MD (SUB_INVESTIGATOR)
Henry Ford HealthDetroitMichigan48202
Mousab M Eteer, MD
[email protected]
989-839-3000
Katherine A Nowak, PhD
[email protected]
Mousab M Eteer, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Michael Manning, MD
[email protected]
859-619-4712
Amy Patrylick
[email protected]
Michael Manning, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest University School of MedicineWinston-SalemNorth Carolina27101
Ashish Khanna, MD
[email protected]
336-716-4498
Lynnette Harris
[email protected]
Ashish Khanna, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Siddharth Dave, MD
[email protected]
214-645-8300
Emily Melikman
[email protected]
Siddharth Dave, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Bhiken Naik, MD
[email protected]
434-924-2547
Meghana Ilendula
[email protected]
Bhiken Naik, MD (PRINCIPAL_INVESTIGATOR)
University of WashingtonSeattleWashington98195
Karen B Domino, MD
[email protected]
Karen B Domino, MD (PRINCIPAL_INVESTIGATOR)
Wil Van Cleve, MD (SUB_INVESTIGATOR)
John Lang, MD (SUB_INVESTIGATOR)

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