Comparing vasopressin and norepinephrine for blood pressure management in cardiac surgery patients
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
This study is testing whether vasopressin can better help manage blood pressure and reduce kidney problems in patients undergoing heart surgery compared to the usual treatment with norepinephrine.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Trial ID | NCT05568160 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, double-blind, multicenter phase 3 study aimed at evaluating the effectiveness of vasopressin versus norepinephrine in maintaining blood pressure in patients undergoing cardiac surgery with extracorporeal circulation. The study plans to enroll 840 patients, focusing on those at risk of acute renal failure and/or death due to vasoplegic syndrome. Participants will be monitored closely post-surgery with follow-ups on days 1, 2, 7, 30, and 90 to assess outcomes related to kidney function and overall health. The primary goal is to determine if vasopressin can reduce the incidence of acute renal failure compared to the standard treatment with norepinephrine.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for cardiac surgery with extracorporeal circulation who have multiple risk factors for acute kidney failure.
Not a fit: Patients who do not require cardiac surgery or those without significant risk factors for acute kidney failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of blood pressure in cardiac surgery patients, potentially reducing the risk of acute kidney failure and mortality.
How similar studies have performed: Other studies have explored the use of vasopressin in similar contexts, but this specific comparison with norepinephrine in cardiac surgery is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Dijon
- Chu Dijon Bourgogne — Dijon, France (Recruiting)
Study contacts
- Study coordinator: Pierre-Grégoire GUINOT
- Email: pierre-gregoire.guinot@chu-dijon.fr
- Phone: 0380281309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.