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临床试验/EUCTR2009-016785-88-BE
EUCTR2009-016785-88-BE进行中(未招募)不适用

Dexmedetomidine pharmacokinetics-pharmacodynamicsin mechanically ventilated children with single-organ respiratory failure

niversity Hospital Ghent0 个研究点开始时间: 2009年11月12日最近更新:
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 admitted to the paediatric intensive care unit
  • - expected to require at least 24h of mechanical ventilation
  • - patient age : 1 month-15 years
  • - patients with single-organ respiratory failure
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
  • - no arterial catheter in place at inclusion
  • - patients who have received another investigational drug within 30 days
  • - patients on continuous infusion with neuromuscular blockers
  • - patients with a life expectancy <72h
  • - patients with a known allergy to lorazepam, midazolam and/or morphine
  • - heart block
  • - pre-existing bradycardia
  • - hemodynamically unstable patients (Wernovsky index > 16 points) after full fluid replacement with cristalloid
  • - paients with significant renal insufficiency (creatinine plasma level 1 month-5 year : > 1 mg/dl ; 5-10 years : >1.2 mg/dl; > 10 years : > 1.5 mg/dl)
  • - patients with significant hepatic insufficiency (aspartate aminase >950 UI/L and prothrombin time < 60 or INR >1.4)
  • - previous treatment with a2-adrenoreceptor agonist clonidine within 14 days

研究者

发起方
niversity Hospital Ghent

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