Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- rate of abdominal complications
研究概览
简要总结
The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.
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
- None
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
- •Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
排除标准
- •Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders
研究组 & 干预措施
Goal directed therapy intravenous restricitve fluid protocol
干预措施: Goal Directed Intravenous Restrictive Fluid Therapy (Drug)
Control arm
干预措施: Conventional Intravenous Fluid therapy (Drug)
结局指标
主要结局
rate of abdominal complications
时间窗: 90 day postoperative complication
次要结局
- Overall Survival(90 day overall survival)
研究者
Ester Forastiere
M.D., Chief of Critical Area Department
Regina Elena Cancer Institute
