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临床试验/EUCTR2014-001461-27-ES
EUCTR2014-001461-27-ES进行中(未招募)不适用

Evaluation of the effect of organic preservation with the use of levosimendan after cardiac surgery in patients with low output syndrom compared with dobutamine. - FIM-BGC-2014-01

FIMABIS0 个研究点开始时间: 2014年10月16日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

  • Patients where inotropic support is considered appropiate because of a diagnosis of low cardiac output, cardiac index, which remains below 2 L/min/m2 with POP greater than 15 mmHg and / or less than 65% satVO2) syndrome.
  • 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 60
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • . History of adverse reaction to levosimendan.
  • ? Combined surgery (eg valve repair or carotid surgery).
  • ? Patients in situations of hemodynamic instability.
  • ? preoperative renal dysfunction, estimated by the rate of preoperative GFR (creatinine clearance <50ml/min).
  • ? Hypersensitivity to levosimendan or any of the excipients.
  • ? significant mechanical obstructions affecting ventricular filling or emptying, or both.
  • ? History of Torsades de Pointes.
  • ? Status of cardiogenic shock (lactate> 4 mmol / L)

研究者

发起方
FIMABIS

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