Prospective randomized double-blind study evaluating the superiority of VAsopressin versus NOradrenaline in the management of the renal risk patient undergoing cardiac surgery with extracorporeal circulation

Centre Hospitalier Universitaire Dijon Bourgogne0 个研究点目标入组 840 人开始时间: 2022年5月5日最近更新: 2024年7月22日

适应症

试验速览

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•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

•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

发起方

Centre Hospitalier Universitaire Dijon Bourgogne