NCT06802224 The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
| NCT ID | NCT06802224 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Francisco |
| Condition | Anesthesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 18,000 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 18,000 participants in total. It began in 2025-04-01 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Age 18 years or older * Surgery under general anesthesia with a surgery duration of 2 hours or more * Received intravenous vasopressors during surgery Exclusion Criteria: * Cardiac surgery * Extra-corporeal membrane oxygenation * Organ transplantation * Obstetric procedures * Procedures on the kidney * Outpatient procedures * Already receiving NE or PE or inotropes before induction of anesthesia (at the time of anesthesia start) * American Society of Anesthesiologists physical status classification 5 or 6 * Patient for whom a local protocol recommends a specific first line vasopressor * Most recent documented estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73m\^2 or preoperative renal replacement therapy within 60 days before surgery * Patients who do not have a preoperative creatinine value within 60 days before surgery * Alive patients who do not have a postoperative creatinine value
Contact & Investigator
Sachin Kheterpal, MD MBA
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06802224 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anesthesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06802224 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06802224 currently recruiting?
Yes, NCT06802224 is actively recruiting participants. Contact the research team at matthieu.legrand@ucsf.edu for enrollment information.
Where is the NCT06802224 trial being conducted?
This trial is being conducted at San Francisco, United States, College Park, United States, Ann Arbor, United States, Detroit, United States and 6 additional locations.
Who is sponsoring the NCT06802224 clinical trial?
NCT06802224 is sponsored by University of California, San Francisco. The principal investigator is Sachin Kheterpal, MD MBA at University of Michigan. The trial plans to enroll 18,000 participants.