Evaluation of the Superiority of VAsopressin Versus NOradrenaline in the Management of Patients at Risk of Kidney Failure Undergoing Cardiac Surgery With Extracorporeal Circulation

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DIJON · Oct 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a medication called vasopressin compared to noradrenaline for patients at risk of kidney failure who are undergoing heart surgery with a heart-lung machine (extracorporeal circulation). The main goal is to find out if using vasopressin helps to prevent kidney failure and reduces the risk of death better than the usual treatment with noradrenaline. The trial will involve about 840 patients, with a focus on those who have low blood pressure after surgery, a condition known as vasoplegic syndrome.

To participate in this study, patients must be adults scheduled for heart surgery that involves the heart-lung machine and have at least three risk factors for kidney failure, such as being over 70 years old or having diabetes. If eligible, participants will have their health monitored closely over several days after surgery and again at one and three months later. It’s important to know that certain patients, like those needing emergency surgery, pregnant women, or those with specific health conditions, will not be able to participate in this trial.

Gender

ALL

Eligibility 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)