DRUG
Vasopressin
The infusion is started at 5 ml hr-1, increased in increments of 1 ml hr-1 every 5 minutes to reach a maximum target rate of 30 ml hr-1
Status
Active, not recruiting
Phase
Phase 3
Enrollment
840
Locations
1
Results
Not posted
Publications
1
Study summary
This is a randomized, double blind, multicenter study following surgery with extracorporeal circulation to compare blood pressure optimization with vasopressin versus noradrenaline. It is planned to include 840 patients in order to have 420 patients with vasoplegic syndrome. The primary objective of this study is to determine whether the use of vasopressin to maintain blood pressure following cardiac surgery decreases the number of patients with acute renal failure and/or death compared with the usual use of norepinephrine. Participation in the study involves daily follow-up at D1, D2, and D7 of the onset of the syndrome and then follow-up at D30 and D90.
Interventions
DRUG
The infusion is started at 5 ml hr-1, increased in increments of 1 ml hr-1 every 5 minutes to reach a maximum target rate of 30 ml hr-1
DRUG
The infusion is started at 5 ml h-1, increased in increments of 1 ml h-1 every 5 minutes to a maximum target rate of 30 ml h-1
OTHER
At D1, D2, D7, D30 or D60 and D90
OTHER
At the anesthesia consultation, discharge from intensive care, D7, D30 and D90
Timeline
First posted
Oct 5, 2022
Study start
Jan 2, 2023
Primary completion
Mar 2026
Study completion
Mar 2026
Results posted
Not reported
Registry updated
Dec 22, 2025
Outcomes
Occurrence of a renal complication or death
Time frame · From the onset of the vasoplegic syndrome until 7 days after
Not reported in the indexed record.
Eligibility
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)
Study locations
France. Showing up to 24 locations stored in the fast local snapshot.
Chu Dijon Bourgogne
Dijon, France
Related trials
First Affiliated Hospital, Sun Yat-Sen University · Liver Neoplasms · Postoperative Complications
Not applicable
Completed
161
2026-07
Montefiore Medical Center · Cervical Preparation
Phase 1
Recruiting
94
2026-07
Elizabeth Austen Lawson · Vasopressin Deficiency
Phase 1
Recruiting
40
2026-07
Massachusetts General Hospital · Arginine Vasopressin Deficiency · Oxytocin Deficiency
Early Phase 1
Recruiting
20
2026-07
Zhaoyun Zhang · Craniopharyngiomas · Pituitary Macroadenoma
Phase 4
Enrolling by invitation
152
2026-07
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremias · Water Intoxication
Phase 3
Completed
205
2026-07
Otsuka Pharmaceutical Development & Commercialization, Inc. · Hyponatremia
Phase 3
Completed
243
2026-07
Beijing Friendship Hospital · Kidney Transplant · Delayed Graft Function
Not applicable
Active, not recruiting
150
2026-07
Related PeptideStat pages
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.