Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- osmolality
研究概览
简要总结
About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.
The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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 patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund
排除标准
- •heart failure with left ventricular ejection fraction below 50%
- •small size (defined as bodyweight less than 50 kg)
- •anaemia with haematocrit less than 24%
- •patients with previous cardiac surgery
- •patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass
- •patients with peroperative complications including massive peroperative fluid transfusions
结局指标
主要结局
osmolality
时间窗: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.
This study uses blood samples that are taken at predefined timepoints.
次要结局
- urine outcome(Measurements will be taken during first 24 hours following cardiac surgery)