Starch or Saline After Cardiac Surgery (SSACS)
Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
When people undergo major surgery, they require intravenous supplementation of fluids for a number of reasons:
- to compensate for no oral intake
- to support blood pressure and organ function during and after surgery
- to replace lost fluid or blood volume
There are a variety of fluid choices doctors have to provide to patients, and it is still not definitively known whether some fluids are better than others in specific situations. This is a particularly interesting question in patients undergoing heart surgery because of the significant volume of fluids used over the entire course of hospitalization, including before the operation, during the operation, and after the operation.
There has been some scientific evidence that the use of starch-based fluids (synthetic colloids) leads to better oxygen delivery to the organs with a smaller volume of fluid given, providing for better recovery from surgery. However, there has also been some scientific evidence that the use of these fluids can harm kidney function. Importantly, none of these large-scale studies were carried out specifically in patients undergoing heart surgery.
The purpose of this study is to answer the question of whether the use of starch-based fluid in the heart surgery patient makes for a safer and faster recovery, causes kidney dysfunction, or makes no discernable difference.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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London、Ontario、加拿大、N6A 5A5
- London Health Sciences Centre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients undergoing elective primary isolated on-pump coronary artery bypass grafting
Exclusion Criteria:
- pregnant patients
- patients with an active intra-cranial bleed
- patients with a history of hypersensitivity to starch solutions
- patients with Stage 4 or 5 Kidney Disease (estimated glomerular filtration rate < 30 ml / min / 1.73 m2)
- patients with a significant preoperative metabolic acidosis, defined by a preoperative capillary blood pH less than or equal to 7.2 and a serum bicarbonate less than 15
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Starch group
Patients randomized to the Starch group will receive Voluven (6% Hydroxyethyl Starch 130/0.4) for their intravenous bolus and fluid resuscitation requirements.
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有源比较器:Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Incidence of acute kidney injury as defined by RIFLE criteria
大体时间:Short term (in hospital, up to 30 days) and mid-term (2 months)
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Short term (in hospital, up to 30 days) and mid-term (2 months)
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Maximum postoperative weight gain
大体时间:Short-term (in hospital, up to 7 days)
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Short-term (in hospital, up to 7 days)
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Operative mortality
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of ventilation support requirements
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Total chest tube drainage (until removed)
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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ICU length of stay
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Transfusion of blood products
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Incidence of atrial fibrillation (necessitating a change in medical management)
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Duration of oxygen supplementation
大体时间:In hospital (up to 30 days)
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In hospital (up to 30 days)
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Creatinine, Urea, Cr Clearance as estimated by the MDRD formula
大体时间:In hospital at defined timepoints, and at 2 months post hospital discharge
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In hospital at defined timepoints, and at 2 months post hospital discharge
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Volume of fluid infused
大体时间:In hospital (up to 7 days)
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In hospital (up to 7 days)
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Total hospital length of stay (when ready to leave tertiary hospital setting)
大体时间:In hospital
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In hospital
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合作者和调查者
调查人员
- 研究主任:Dave Nagpal, MD、LHSC / UWO
- 首席研究员:Ray Guo, MD、LHSC / UWO
- 首席研究员:Chris Harle, MD、LHSC / UWO
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- LHSC
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