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临床试验/NCT00766519
NCT00766519已完成4 期

Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study

University Hospital, Lille9 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2009年2月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
104
试验地点
9
主要终点
Total number of patients with complications

研究概览

简要总结

The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery

详细描述

Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intrabdominal surgery. In these studies, however, the number of patients was often small, and management in control groups as well as postoperative complications were usually not precisely defined. In addition, widespread use of oesophageal doppler cannot be advocated in routine surgery, and the strategy necessitates repeated volume loading. This may lead to unnecessary intravenous fluids which may be deleterious, and intraoperative fluid restriction has also been shown to improve clinical outcome. In this context, indices reflecting the hemodynamic changes during mechanical ventilation (the so-called "dynamic indices", and more specifically the respiratory-induced pulse pressure variation) have been shown to accurately predict fluid responsiveness in mechanically ventilated patients. Automated and continuous calculation of pulse pressure variation variation from standard peripheral (typically radial) arterial line has recently been validated. This study was thus designed to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on pulse pressure variation monitoring would improve outcome after intrabdominal surgery.

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, Investigator, 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

入选标准

  • major elective intrabdominal surgery

排除标准

  • arrhythmia
  • hepatectomy
  • associated thoracic surgery
  • laparoscopy
  • pregnancy
  • allergy to colloid solution or anesthesia protocol
  • arterial catheter not possible

研究组 & 干预措施

Optimization

Experimental

volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading

干预措施: volume optimization (Other)

control; standard volume administration

Active Comparator

standard volume administration

干预措施: standard volume administration (Other)

结局指标

主要结局

Total number of patients with complications

时间窗: first 7 postoperative days

次要结局

  • total number of complications(first 7 postoperative days)
  • Duration of hospital stay(postoperative)
  • SOFA (Sequential Organ Failure Assessment) score(postoperative days 1 and 5)
  • duration of stay in intensive care unit(postoperative)
  • death(in-hospital and postoperative day 28)
  • volumes of fluid administered(duration of surgery)
  • Time to initial passage of flatus and feces(postoperative)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (9)

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