NCT01946269Unknown3 期
Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Composite endpoint of death or major postoperative complications
研究概览
简要总结
The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.
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
- Double (Participant, 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
- •Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment
- •Age over 18 years-old
排除标准
- •Weight under 55 kilograms or over 140 kilograms;
- •Contra-indication for invasive hemodynamic monitoring;
- •Expected ICU permanence less than 24 hours;
- •Active bleeding
- •Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min
- •Enrolled in other study
- •Refuse to consent
结局指标
主要结局
Composite endpoint of death or major postoperative complications
时间窗: 30 days after randomization
Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.
次要结局
- Duration of ICU stay and hospital stay(30 days after randomization)
- Tissue hypoperfusion markers(7 days after randomization)
- Daily SOFA score(7 days after randomization)
- Cardiovascular complications(30 days after randomization)
- Respiratory complications(30 days after randomization)
- Severe Renal complication(30 days after randomization)
- Neurological complications(30 days after randomization)
- Severe infectious complications(30 days after randomization)
- Surgical complications(30 days after randomization)
研究者
Ludhmila Abrahão Hajjar
Principal Investigator
University of Sao Paulo
研究点 (2)
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