Effect of 130/0.4 Hydroxyethyl Starch vs. Balanced Crystalloid for Intraoperative Fluid Therapy on Major Composite Renal Outcomes After Cardiac Surgery: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,292
- 试验地点
- 4
- 主要终点
- Incidence of major adverse kidney events (MAKE)
研究概览
简要总结
This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery
排除标准
- •Emergency surgery;
- •Planned implantation of a durable left ventricular assist device;
- •History of starch allergy or hypersensitivity;
- •History of kidney transplantation;
- •Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT);
- •Preoperative glomerular filtration rate < 30 mL/min/1.73 m2;
- •Planned intraoperative and postoperative RRT;
- •Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.);
- •Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count <100,000/µL);
- •Active infective endocarditis.
研究组 & 干预措施
Ballanced crystalloid
Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required [e.g., preload augmentation, intravascular volume replacement] during cardiac surgery).
干预措施: Crystalloid solutions (Drug)
Hydroxyethyl starch
Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery
干预措施: Volulyte® (6% HES 130/0.4 in balanced solution) (Drug)
结局指标
主要结局
Incidence of major adverse kidney events (MAKE)
时间窗: For up to 7 days post-surgery
The incidence of a composite outcome consinsting of all-cause mortality (patients who dies from any cause after surgery), stage 2 (an increase in serum creatinine to 2.0-2.9 times the baseline value) or stage 3 (an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL) acute kidney injury, or new requirement for renal replacement therapy (de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery).
次要结局
- Vasopressor-free days(For up to 7 days post-surgery)
- Vasopressor-free days(For up to 14 days post-surgery)
- Generalized average real variability(From intensive card unit admission after surgery to 6 hours post-admission)
- Vasopressor-free days(From intensive care unit admission after surgery to postoperative day 14)
- Peak increase in serum creatinine(From entollment to postoperative day 3)
- Maximum stage of acute kidney injury(From the end of surgery to postoperative day 7)
研究者
Karam Nam, MD
Clinical Associate Professor
Seoul National University Hospital