2022-500419-38-00招募中3 期
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 Bourgogne6 个研究点 分布在 1 个国家目标入组 840 人开始时间: 2022年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 840
- 试验地点
- 6
- 主要终点
- Occurrence of a renal complication or death from the onset of vasoplegic syndrome until 7 days after. Renal complications are defined as the occurrence of acute kidney failure as defined by the KDIGO definition (stage 1 or higher), and/or the initiation of renal replacement therapy
研究概览
简要总结
To compare 2 blood pressure optimization strategies (vasopressin versus norepinephrine) on the occurrence of a composite end point combining renal complications and death at D7 of the onset of vasoplegic syndrome in patients undergoing cardiac surgery with extracorporeal circulation.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Occurrence of a renal complication or death from the onset of vasoplegic syndrome until 7 days after. Renal complications are defined as the occurrence of acute kidney failure as defined by the KDIGO definition (stage 1 or higher), and/or the initiation of renal replacement therapy
Occurrence of a renal complication or death from the onset of vasoplegic syndrome until 7 days after. Renal complications are defined as the occurrence of acute kidney failure as defined by the KDIGO definition (stage 1 or higher), and/or the initiation of renal replacement therapy
次要结局
- The occurrence of a renal complication (as defined in the primary endpoint) or death within 90 days of the onset of vasoplegic syndrome
- Mortality within 90 days of the onset of vasoplegic syndrome
- Occurrence of a cardiac complication as listed below at 7, 30, and 90 days after the onset of vasoplegic syndrome: arrhythmia requiring treatment , postoperative myocardial damage, myocardial infarction defined by an increase in cardiac enzymes plus the appearance of a new Q wave, and/or an abnormality of kinetics on echocardiography, cardiorespiratory arrest
- The occurrence of a digestive complication as listed below at 7, 30 and 90 days after the onset of the vasoplegic syndrome: mesenteric ischemia, ischemic colitis diagnosed by an imaging examination (CT scan, endoscopy) or the need for a reoperation for digestive complication in the aftermath of the cardiac surgery
- The occurrence of a cerebral complication as listed below within 7 days of the onset of the vasoplegic syndrome: stroke, delirium (identified by the CAM-ICU test)
- The number of patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively
- The total dose (mg) of norepinephrine for patients requiring rescue norepinephrine after the onset of vasoplegic syndrome in the OR and postoperatively
- The Vasoactive Inotropic Score at D0, D1, D2, D7 of the onset of the vasoplegic syndrome (VIS = dopamine dose (mcg kg-1 min-1) + dobutamine dose (mcg kg-1 min-1) + 100 x adrenaline dose (mcg kg-1 min- 1) + 10 x dose of milrinone (mcg kg-1 min-1) + 10,000 x dose of vasopressin (units/kg/min) + 100 x dose of norepinephrine (mcg kg-1 min-1) + 10 x dose of phenylephrine (mcg kg-1 min-1)
- The length of stay in the ICU and hospital (number of days) at D90 of the onset of the vasoplegic syndrome
- The difference in mean costs of ICU and hospital stays at D90 of vasoplegic syndrome onset
- The incremental cost-effectiveness ratio at D90 of onset of vasoplegic syndrome, expressed as the cost per additional complication avoided by the vasopressin strategy compared with the noradrenaline strategy
- The incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed as the cost per additional year of life gained with the vasopressin strategy compared with the noradrenaline strategy
- Incremental cost-effectiveness ratio at D90 of the onset of vasoplegic syndrome, expressed in terms of cost per additional healthy life-year gained (cost/QALY) with the vasopressin strategy compared with the noradrenaline strategy
- The occurrence of hyponatremia (Na+ <130 mmol l-1), hypoperfusion of the extremities (cyanosis/necrosis of the extremities) at D7
研究者
Chef de projets recherche
Scientific
Centre Hospitalier Universitaire Dijon Bourgogne
研究点 (6)
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