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Evaluating the superiority of VAsopressin versus NOradrenaline in the management of the renal risk patient undergoing cardiac surgery with extracorporeal circulatio

Phase 1
Recruiting
Conditions
vasoplegic syndrome
MedDRA version: 21.1Level: LLTClassification code: 10067654Term: Vasoplegic syndrome Class: 10022117
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
CTIS2022-500419-38-00
Lead Sponsor
Centre Hospitalier Universitaire Dijon Bourgogne
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
840
Inclusion Criteria

Patient who has given free, written and informed consent, Patient of legal age, Patient requiring cardiac surgery: o Scheduled (> 24h) o With extracorporeal circulation (ECC) o 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, LVEF <40%, redux, intra-aortic counterpulsation balloon, expected duration of bypass surgery > 100 min, albuminuria, Negative pregnancy test for women of childbearing age

Exclusion Criteria

Patient not affiliated to national health insurance or not beneficiary of a social security system, 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®, 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

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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