Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Postoperative complications
研究概览
简要总结
Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?
The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.
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
- Single (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
- •Adult ASA class III & IV (high risk) patients
- •>18 years
- •scheduled for gastrointestinal surgery involving laparotomy
- •Both elective and emergency cases
排除标准
- •Atrial fibrillation
- •Mental impairment, unable to give informed consent
- •Severe aortic or mitral stenosis
- •Type of surgery: Liver surgery, transthoracic oesophagectomy
研究组 & 干预措施
Control
Standard monitoring. Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate. Followed by an infusion of 10ml/kg/t Ringer acetate. Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t. Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary. Postoperative give 1000ml Glucose 5%. HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent.
Goal directed fluid therapy
干预措施: Goal directed fluid therapy guided by LiDCOrapid (Procedure)
结局指标
主要结局
Postoperative complications
时间窗: 5 days after surgery
次要结局
- Renal function(5 days after surgery)
- Complications until discharge and readmission within 30 days(3 month after surgery)
- Mortality within 30 days and 3-month after surgery(3 month after surgery)
- Length of hospital stay(3 month after surgery)
- Vasoactive agents need(3 month after surgery)