The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Su… (NCT06802224) | Clinical Trial Compass
RecruitingPhase 4
The Choice of Vasopressor to Prevent Postoperative Acute Kidney Injury After Major Non-Cardiac Surgery
United States, Canada18,000 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing different vasopressors used during surgery to prevent acute kidney injury — do you think my kidney function puts me at higher-than-average risk for AKI after major surgery, and would that make this trial particularly relevant to discuss for my situation?
2Since this is a Phase 4 trial, the vasopressors being tested are already approved and in use — does that mean the safety profile is better understood than in earlier-phase trials, and what does that mean for my personal risk if I were to participate?
3The trial is also tracking myocardial injury after noncardiac surgery (MINS) as part of its focus — given my heart health, should I be concerned about that risk during my planned surgery regardless of whether I join this trial?
4How would being in this trial actually affect my surgery day — for example, would the choice of vasopressor used to manage my blood pressure be determined by the study rather than by your clinical judgment in the moment?
5If I don't join this trial, what vasopressor would you typically use to manage my blood pressure during surgery, and do you think the current standard approach is already the best option for protecting my kidneys?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.