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临床试验/NCT03141411
NCT03141411已完成不适用

Assisted Versus Manual Goal Directed Fluid Therapy in Major Abdominal Surgery

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2017年5月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
percentage time spent with SVV < 13%

研究概览

简要总结

Goal-directed fluid therapy (GDFT) strategies based on cardiac output (CO) optimization have been shown to benefit moderate- to high-risk surgery patients and have recently been recommended by professional societies in the UK, in France, and in Europe. However, despite the growing evidence, these strategies are often not implemented in current practice. One of the reasons for this lack of implementation is that GDFT strategies, like any other complex clinical protocol, require significant provider attention and vigilance for consistent implementation and it is well known that even under study conditions protocol compliance rates are often not greater than 50%. To overpass this problem, our CO monitoring devices (EV1000, Edwards Lifesciences) have now an incorporated assisted fluid management software. This software determines fluid responsiveness by estimating the predicted change in stroke volume and suggests to the anesthesiologist when fluid is required .

详细描述

The aim of this study was to assess an assisted fluid management strategy in a moderate-to-high risk surgical cohort and compare that cohort to matched patients who received manual GDFT. Our hypothesis was that the assisted fluid management system would result in higher mean percentage time spent during surgery with a SVV < 13%

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • All patients undergoing major abdominal surgery and requiring a CO monitoring for fluid management

排除标准

  • Emergency surgery Arrhythmia (e.g. atrial fibrillation) Aortic regurgitation

结局指标

主要结局

percentage time spent with SVV < 13%

时间窗: intraoperative period

defined as preload independent state

次要结局

  • amount of vasopressors required(intraoperative period)
  • PACU/ICU and hospital length of stay(until 30 days post surgery)
  • amount of fluid administered(intraoperative period)
  • fluid balance(intraoperative period)
  • incidence of major and minor complications(until 30 days post surgery)

研究者

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

研究点 (1)

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