2024-517771-21-00招募中4 期
A Prospective Angiotensin II versus Noradrenaline trial for Hypotension management to reduce cardiac-surgery associated Acute Kidney Injury (PAN-AKI)
Universitaet Muenster15 个研究点 分布在 1 个国家目标入组 1,022 人开始时间: 2025年2月6日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,022
- 试验地点
- 15
- 主要终点
- Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after cardiac surgery
研究概览
简要总结
To investigate the effect of angiotensin II as primary vasopressor on the occurence of moderate or severe acute kidney injury within 72 hours after cardiac surgery
研究设计
- 分配方式
- Randomized
- 主要目的
- Angiotensin II vs Norepinephrine in PAN-AKI allocation and interim analysis
- 盲法
- Double (Monitor, Subject, Analyst, Carer, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Cardiac surgery using cardiopulmonary bypass including coronary artery bypass grafting (CABG) surgery, valve surgery, or combined CABG/valve surgery
- •Elevated risk of AKI as predicted by a score ≥ 1.5 on the following scale: a. hemoglobin < 130g/l = 2 b. creatinine > 1.1 mg/dl = 2 c. age > 70 years =1.5 d. NYHA 4 =1.5 e. BMI > 30 =1.5
- •Adult ≥ 18 years
- •Written informed consent
排除标准
- •Major aortic surgery (aortic arch replacement), transplant surgery, pulmonary thrombendarterectomy, ventricular assist device placement
- •Persons with any kind of dependency on the investigator or employed by the sponsor/investigator
- •Participation in another interventional trial within the last three months that investigates kidney function
- •Already receiving inotropic/vasopressor support before surgery
- •Dialysis dependent
- •Pre-existing AKI within the last 30 days
- •Pre-existing chronic kidney injury with an eGFR<20 ml/min/1.73m2
- •Pre-existing significant hypertension (persistent SBP > 180mmHg)
- •Significant pulmonary hypertension (ePSAP > 70mmHg, mPAP > 40mmHg) with right ventricular systolic dysfunction (graded more severe than mild)
- •Hypersensitivity to the active substance or to any of the excipients of angiotensin II and norepinephrine (e.g. sodium metabisulfite, sulfite, chlorobutanol hemihydrate and sodium chloride and water)
- •Pregnancy (a negative pregnancy test for women of childbearing age) or breastfeeding women
结局指标
主要结局
Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after cardiac surgery
Rate of AKI KDIGO stage 2 or 3 or death within 72 hours after cardiac surgery
次要结局
- MAKE90 (consisting of mortality, any dialysis within 90 days, persistent renal dysfunction (defined as > 25% eGFR reduction to baseline value at day 90)
- Development or progression of chronic kidney disease based on albuminuria and on two serum creatinine measurements between day 90 and 120
研究者
Principal Coordinating Investigator
Scientific
Universitaet Muenster
研究点 (15)
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