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临床试验/NCT01882920
NCT01882920已完成不适用

Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study

Regina Elena Cancer Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年6月最近更新:
适应症
干预措施

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

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

Experimental

干预措施: Goal Directed Intravenous Restrictive Fluid Therapy (Drug)

Control arm

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ester Forastiere

M.D., Chief of Critical Area Department

Regina Elena Cancer Institute

研究点 (1)

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