NCT00337805已完成2 期
A Randomized Trial of Synthetic vs Normal Saline for the Flow-based Algorithmic Hemodynamic Resuscitation of Patients Post-cardiac Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Use of catecholamines at 8:00 the morning after surgery
研究概览
简要总结
This is a randomized double blind trial of the use of the use of colloids vs crystalloid solutions for resuscitation of patients after cardiac surgery. Patients are managed with an algorithm driven protocol that is based on the flow response to fluid challenges. The hypothesis is that the use of a colloid solution will result in less use of catecholamines at 8:00 the morning following surgery. Secondary end-points include total use of catecholamines, time in the ICU, return to the ICU, and safety issues including bleeding and renal function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •status post cardiac surgery
- •pulmonary artery occlusion catheter in place
- •informed consent
- •morning case (must be out of OR by 2:00 PM
排除标准
- •excessive bleeding (> 200 cc/hr)
- •intraaortic balloon pump
- •refusal by treating team
- •emergency cases
- •patients with known adverse reactions to starch solutions
结局指标
主要结局
Use of catecholamines at 8:00 the morning after surgery
时间窗: first post operative day
次要结局
- Total use of catecholamines(Time in ICU)
- Time in the ICU(Time in ICU)
- Post-operative complications(Hospital stay or 28 days)
- Bleeding(Hospital stay or 28 days)
- Renal failure(Hospital stay or 28 days)
研究者
研究点 (2)
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