RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Norepinephrine vs Phenylephrine as the First-line Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-cardiac Surgery

Quick Facts

Study Start:2025-04-01
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06802224

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * Surgery under general anesthesia with a surgery duration of 2 hours or more
  3. * Received intravenous vasopressors during surgery
  1. * Cardiac surgery
  2. * Extra-corporeal membrane oxygenation
  3. * Organ transplantation
  4. * Obstetric procedures
  5. * Procedures on the kidney
  6. * Outpatient procedures
  7. * Already receiving NE or PE or inotropes before induction of anesthesia (at the time of anesthesia start)
  8. * American Society of Anesthesiologists physical status classification 5 or 6
  9. * Patient for whom a local protocol recommends a specific first line vasopressor
  10. * Most recent documented estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m\^2 or preoperative renal replacement therapy within 60 days before surgery
  11. * Patients who do not have a preoperative creatinine value within 60 days before surgery
  12. * Alive patients who do not have a postoperative creatinine value

Contacts and Locations

Study Contact

Matthieu Legrand, MD PhD
CONTACT
415-476-9035
matthieu.legrand@ucsf.edu
Michael P. Bokoch, MD PhD
CONTACT
415-476-8389
michael.bokoch@ucsf.edu

Principal Investigator

Sachin Kheterpal, MD MBA
PRINCIPAL_INVESTIGATOR
University of Michigan
Matthieu Legrand, MD PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Allison Janda, MD
STUDY_DIRECTOR
University of Michigan
Michael P Bokoch, MD PhD
STUDY_DIRECTOR
University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Sachin Kheterpal, MD MBA, PRINCIPAL_INVESTIGATOR, University of Michigan
  • Matthieu Legrand, MD PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Allison Janda, MD, STUDY_DIRECTOR, University of Michigan
  • Michael P Bokoch, MD PhD, STUDY_DIRECTOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2028-07

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Norepinephrine
  • Phenylephrine
  • Major adverse kidney events
  • Pragmatic
  • Cluster randomized
  • Crossover

Additional Relevant MeSH Terms

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