Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,102
- 试验地点
- 3
- 主要终点
- Number of Participants With Postoperative Morbidity (Major Complications)
研究概览
简要总结
A trial in which patients having open abdominal surgery are randomized to receive either crystalloids or colloids intraoperatively, guided by esophageal Doppler. The investigators test the primary hypothesis that goal-directed colloid administration during elective abdominal surgery decreases a composite of postoperative complications within 30 days of surgery.
详细描述
Patients will be given 5-7 ml/kg of crystalloid (lactated Ringer's) in the immediate preoperative period, which will be followed by 4 ml/kg/h crystalloid for maintenance normalized to ideal body weight [Men: Ideal Body Weight (in kilograms) = 52 kg + 1.9 kg for every 2.5 cm over 150 cm; Women: Ideal Body Weight (in kilograms) = 49 kg + 1.7 kg for every 2.5 cm over 150 cm].
They will then be randomly assigned to additional volume replacement, guided by esophageal Doppler, to either lactated Ringer's solution of Voluven starch.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status 1-3
- •Body Mass Index < 35
- •Moderate risk elective abdominal surgical procedures scheduled to take ≥ two hours done under general anesthesia.
排除标准
- •cardiac insufficiency (EF<35%)
- •coronary disease with angina (NYHA IV)
- •severe chronic obstructive pulmonary disease
- •coagulopathies
- •symptoms of infection or sepsis
- •renal insufficiency (creatinine clearance <30ml/min or renal replacement therapy)
- •ASA Physical Status > 3.
研究组 & 干预措施
Crystalloid
Lactated Ringers solution will be used for fluid replacement.
干预措施: Crystalloid (Drug)
Colloid
Low-molecular weight colloid HES 130/0.4 (Voluven) will be used for fluid replacement
干预措施: Colloid (Drug)
结局指标
主要结局
Number of Participants With Postoperative Morbidity (Major Complications)
时间窗: Postoperative 30-days
Any of the following major complications: (1) Cardiac (Acute heart failure/Myocardial infarction/Ventricular arrhythmia); (2) pulmonary (embolism/edema/respiratory failure/pneumonia/pleural effusion); (3) gastrointestinal (bowel and surgical anastomosis stricture or anastomotic leak/internal or external fistulas/peritoneal effusions); (4) Renal (requiring dialysis); (5) Infectious (deep or organ space surgical site infection / sepsis); and (6) Coagulation (bleeding).
次要结局
- Number of Participants With Postoperative Complications, 30-day Readmission, and 30-day Death(Postoperative 30 days)
- Number of Participants With Postoperative Acute Kidney Injury(Hospitalization)
- Number of Participants With Postoperative Morbidity (Minor Complications)(Postoperative 30-days)