Heart surgery drug showdown: can vasopressin save more kidneys?
NCT ID NCT05568160
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares vasopressin to the standard drug noradrenaline for managing blood pressure after heart surgery. The goal is to see if vasopressin reduces the number of patients who develop acute kidney failure or die. About 840 adults having scheduled heart surgery with a heart-lung machine will participate, and they will be randomly assigned to receive one of the two drugs.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vasopressin
- What this could lead to
- If vasopressin works better than noradrenaline, it could become a new standard to prevent kidney failure and reduce deaths after heart surgery.
- What could go wrong
- This is a large phase 3 trial, but results may not show a clear benefit over the current drug. Kidney protection is complex, and individual responses vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 840 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient who has given free, written and informed consent * Patient of legal age. * Negative pregnancy test for women of childbearing age * Patient requiring cardiac surgery: * Scheduled (\> 24h) * With extracorporeal circulation (ECC) * Myocardial revascularization (coronary bypass), and/or surgical correction of valvulopathy (aortic, mitral, pulmonary, tricupsidian), and/or of the ascending aorta and/or removal of an intracardiac tumor, and/or closure of a PFO/ASD * Patient with at least 3 risk factors for acute kidney failure including: * age \> 70 years, combined surgery (more than two procedures), common trunk lesion, preoperative anemia, chronic respiratory failure, obliterative arterial disease of the lower extremities, diabetes, glomerular filtration \< 60 ml min-1 m², LVEF \<40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery \> 100 min, albuminuria Exclusion Criteria: * Patient not affiliated to national health insurance or not beneficiary of a social security system, * Patient subject to a measure of legal protection (curatorship, guardianship), * Pregnant, parturient or breastfeeding women, * Patients of legal age who are incapable or unable to express their consent, * Patients who have already been included in this study * Patients requiring emergency surgery (less than 24 hours) * Patient with chronic kidney failure on dialysis, * Patient with a cardiac transplant, * Patient on left-sided monoventricular assistance, * Patient on ECMO/ECLS, * Patient with acute circulatory failure in the immediate preoperative period (sepsis, hemorrhage), * Patients with known hypersensitivity to the active ingredient (argipressin) or to one of the excipients of REVERPLEG®. Secondary exclusion criteria: * Patient not developing persistent arterial hypotension (vasoplegic syndrome), within 12 hours after completion of surgery, defined as persistent mean arterial pressure (MAP) \<65 mmHg despite correction of preload and inotropism, with a cardiac index \>2.2 l min-1 m-2, and not responding to 30 mg cumulative of ephedrine in bolus * Patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Chu Dijon Bourgogne
Dijon, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.