EUCTR2021-003088-87-DE进行中(未招募)1 期
Biomarker-guided implementation of angiotensin-II (AT-II) to reduce the occurrence of kidney damage after cardiac surgery - AIDED
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adult patients scheduled for cardiac surgery with cardiopulmonary bypass (CPB),
- •2.18 years of age or older,
- •3.cardiac index > 2.1 l/min per square meter,
- •4.Written informed consent.
- •Registered patients will be randomized only if
- •1.?-renin (difference between post- and pre-operation) = 3.7 µU/ml 4h after CPB.
- •2.postoperative hypotension requiring vasopressors
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 39
排除标准
- •1.Preexisting AKI (stage 1 and higher)
- •2.Patients with cardiac assist devices (ECMO, LVAD, RVAD, IABP)
- •3.Pregnant women, breastfeeding women and women of childbearing potential
- •4.Known (Glomerulo-) Nephritis, interstitial nephritis or vasculitis
- •5.Chronic kidney disease with eGFR < 20 ml/min/1.73m2
- •6.Dialysis dependent CKD
- •7.Prior kidney transplant within the last 12 months
- •8.Emergency surgery in the context of an acute coronary syndrome
- •9.Hypersensitivity to the active substance, or to any of the excipients of the study medication
- •10.Bronchospasm
- •11.Liver failure
- •12.Mesenteric ischemia
- •13.Participation in another intervention trial in the past 3 months
- •14.Persons with any kind of dependency on the investigator or employed by the institution responsible or investigator
- •15.Persons held in an institution by legal or official order
研究者
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