Liberal VS Goal-directed Intraoperative Fluid Therapy in Pediatric Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients with 5% postoperative weight gain between control group and study group
研究概览
简要总结
The objectives of this study are 1) to investigate the influence of different fluid regimen (Liberal regimen versus Goal directed therapy regimen) on postoperative outcome such as weight gain, delayed gut function recovery, pneumonia and 2) to ascertain the reliability of USCOM monitoring using serum lactate and base deficit as control parameters.
详细描述
Liberal regimen = maintenance fluid(4/2/1) + deficit fluid + replacement of third space loss (>,=10ml/kg/h) Goal directed therapy regimen = maintenance fluid + deficit fluid + fluid replaced by hemodynamic monitoring guided.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight < 15 kg
- •Under going major abdominal surgery such as tumor removal, gut obstruction, pull through, etc. under general anesthesia and invasive arterial pressure monitoring if justified
- •ASA < or = 3
- •Duration of surgery > or = 2 hours
排除标准
- •Cardiopulmonary disease
- •Renal insufficiency
- •Intraoperative complications such as massive bleeding, severe hypotension, prolonged need for mandatory ventilation
- •reoperation
研究组 & 干预措施
control group
Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration
干预措施: conventional liberal fluid regimen (Drug)
study group
Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1).
Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index
干预措施: restricted fluid regimen (Drug)
结局指标
主要结局
Proportion of patients with 5% postoperative weight gain between control group and study group
时间窗: 24 hours
Body weight
次要结局
- Amount of intraoperative fluid(1 day)
- Postoperative morbidity(4 days)