EUCTR2007-000390-31-DE进行中（未招募）不适用
Application of hypertonic hyperoncotic solutions for improvement of cardiac output after open heart surgery in children - monocentric, randomised, placebo controlled, double-blind clinical trial (phase IV) - HyperHAES-PÄD-CARDIO-02
niversitätsklinikum Erlangen0 个研究点开始时间: 2009年7月28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
- •Written informed consent of the legal guardian and consent of the patient, if applicable
- •Age: 1 month to 5 years
- •Patients with up to now untreated cyanotic or acyanotic organic heart defects, after open-heart surgery with cardio-pulmonal-bypass
- •Body weight: > 3,5 kg up to < 50 kg
- •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
- •Age > 5 years
- •Body weight < 3,5 kg or >50 kg
- •Known hypersensitivity against hydroxyethyl starch in the patient's history
- •Evidence in the patient's history of hemorrhagic diathesis
- •Pre-surgical manifest heart insufficiency (NYHA-classification: degree IV)
- •Thrombopenia (Thr <50000/mm3) at study inclusion
- •Restricted renal function
- •(creatinin-clearance acc. to Schwartz < 30 ml/min/1,73 m2)
- •Pre-surgical Na > 150 mmol/l
- •Pre-surgical hyperchloremia
- •Calculated serum osmolarity:> 350 mosm/l
- •Acute life threatening hypovolemic shock
- •Dehydration
- •Hyperhydration
- •Oliguria/Anuria
- •Known disturbance of haemostasis
- •Contraindications in the product information (SmPC) of HyperHAES® or Isotonische Kochsalzlösung Fresenius® do apply
- •participation in another clinical trial with an investigational medicinal product.
研究者
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