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临床试验/EUCTR2013-005209-30-BE
EUCTR2013-005209-30-BE进行中(未招募)不适用

The effect of Hydroxyethylstarch 6% 130/0.4 in a balanced electrolyte solution (Volulyte®) compared to gelatine (Geloplasma®) on microvascular reactivity and tissue oxygen saturation during haemodilution measured with near-infrared spectroscopy. - Volulyte® versus Geloplasma®

Ghent University Hospital0 个研究点开始时间: 2013年12月10日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)

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

  • Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (> 32°C) CPB without blood transfusion will be recruited. Age = 18 years.
  • 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 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • Exclusion criteria are an ejection fraction < 25%, a known allergy to HES, admission of HES or gelatines within the preceding 2 weeks, renal insufficiency (creatinine > 2.0 mg/dl), significant hepatic disease (liver function tests > 3x upper limit of normal), history of cerebrovascular disease, significant carotid artery stenosis (> 60%), perioperative use of corticosteroids, and need for vasopressor or inotropic therapy before surgery. An expected haematocrit on CPB, calculated based on preoperative haematocrit, calculated blood volume and amount of cardioplegia, of < 23% is also considered an exclusion criterium (Ranucci 2006).

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