NCT02034682已完成不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.
研究概览
简要总结
The aim of this study is to compare 6% hydroxyethyl starch (HES) 130/0.4 in a balanced electrolyte solution (Volulyte®) with modified fluid gelatin (Geloplasma®) as the priming solution for the cardiopulmonary bypass (CPB) circuit. The microvascular reactivity and the effects on tissue (StO2) and cerebral (ScO2) oxygen saturation will be examined using near-infrared spectroscopy (NIRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult consenting patients scheduled for elective coronary artery bypass grafting surgery on moderately hypothermic (> 32°C) CPB without blood transfusion. Age ≥ 18 years.
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
研究组 & 干预措施
Volulyte 6%
Experimental
- Volulyte 6% (HES 130/0.4 in an isotonic composition). In 1000 ml:
- Maize starch 60 gr. Molar substitution 0.38-0.45. 130000 Da
- Na acetate trihydrate 4.63 gr
- Sodium Chloride 6.02 gr
- Potassium Chloride 0.3 gr
- MgCl 0.3 gr
- Sodium hydroxide-hydrochloric acid & H2O
干预措施: Volulyte 6% (Drug)
Geloplasma
Active Comparator
In 1000 ml:
- Modified fluid gelatin 30 gr
- Sodium Chloride 5.4 gr
- Potassium Chloride 0.37 gr
- MgCl 0.14 gr
- Sodium lactate 3.36 gr
干预措施: Geloplasma (Drug)
结局指标
主要结局
Value of the StO2 recovery slope (recStO2) after postocclusive ischaemia.
时间窗: after 3 minutes of postocclusive ischaemia
Values are measured, using near-infrared spectroscopy.
次要结局
- Change of values of ScO2 during cardiopulmonary bypass (CPB ).(Continuously during cardiopulmonary bypass (= maximum 3 hours).)
- Change of value of StO2 during cardiopulmonary bypass.(Continuously during cardiopulmonary bypass(= maximum 3 hours).)
- Change of blood gas analyses during cardiopulmonary bypass.(Continuously during cardiopulmonary bypass(= maximum 3 hours).)
- Change of haemodynamics during cardiopulmonary bypass.(Continuously during cardiopulmonary bypass(= maximum 3 hours).)
- Urinary output during cardiopulmonary bypass.(At the end of cardiopulmonary bypass(= after maximum 3 hours)..)
- Use of vasoactive medication during cardiopulmonary bypass.(During complete cardiopulmonary bypass(= maximum 3 hours).)
研究者
研究点 (1)
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