Short-term Outcomes of Fluid Replacement and Resuscitation Strategy in the Cardiac Surgery Patient: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury as defined by RIFLE criteria
研究概览
简要总结
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
- 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
- •patients undergoing elective primary isolated on-pump coronary artery bypass grafting
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 6% Hydroxyethyl Starch 130/0.4 (Drug)
Saline group
Patients randomized to the Saline group will receive 0.9% Normal Saline for their intravenous fluid bolus and resuscitation requirements
干预措施: 0.9% Normal Saline (Drug)
结局指标
主要结局
Incidence of acute kidney injury as defined by RIFLE criteria
时间窗: Short term (in hospital, up to 30 days) and mid-term (2 months)
Maximum postoperative weight gain
时间窗: Short-term (in hospital, up to 7 days)
次要结局
- Total chest tube drainage (until removed)(In hospital (up to 30 days))
- Transfusion of blood products(In hospital (up to 30 days))
- Volume of fluid infused(In hospital (up to 7 days))
- Duration of ventilation support requirements(In hospital (up to 30 days))
- ICU length of stay(In hospital (up to 30 days))
- Incidence of atrial fibrillation (necessitating a change in medical management)(In hospital (up to 30 days))
- Creatinine, Urea, Cr Clearance as estimated by the MDRD formula(In hospital at defined timepoints, and at 2 months post hospital discharge)
- Total hospital length of stay (when ready to leave tertiary hospital setting)(In hospital)
- Operative mortality(In hospital (up to 30 days))
- Duration of oxygen supplementation(In hospital (up to 30 days))
研究者
Dave Nagpal
Associate Professor of Cardiac Surgery and Critical Care Medicine, Surgical Director of Heart Failure and Mechanical Circulatory Support Program
London Health Sciences Centre