NCT05568160Active, not recruitingPhase 3
Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Prospective Randomized Double-blind Study Evaluating the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation
Source: ClinicalTrials.gov · Last updated 22 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- First submitted
- 3 Oct 2022
- Start date
- 2 Jan 2023
- Primary completion date
- Mar 2026
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- NCT number
- NCT05568160
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 840
- From 2 Jan 2023 to the primary completion date, Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring emergency surgery (less than 24 hours)
- Patient with hemorrhagic shock perioperatively before receiving vasopressor therapy (treatment under study)
Other illness
- Patient with chronic kidney failure on dialysis,
- Patient with a cardiac transplant,
- 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
Age
- Patients of legal age who are incapable or unable to express their consent,
Other
- 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 who have already been included in this study
- Patient on left-sided monoventricular assistance,
- Patient on ECMO/ECLS,
Who the study is looking for
- 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
Age in the registry: 70 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Dijon Bourgogne Coordinator of this site? Confirm its status | Dijon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.