跳至主要内容
临床试验/EUCTR2021-003088-87-DE
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

Westfälische Wilhelms-Universität Münster0 个研究点目标入组 64 人开始时间: 2021年9月16日最近更新:
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

相似试验