跳至主要内容
临床试验/NCT01939652
NCT01939652已完成早期 1 期

Restrictive Versus Standard Fluid Regime in Elective Minilaparotomy Abdominal Aortic Aneurysm Repair

University Clinical Center Tuzla0 个研究点目标入组 60 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
60
主要终点
Number of major and minor complications

研究概览

简要总结

Elective minilaparatomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal and central nervous system, and mortality ranging up to 5%. In our study, we tested the hypothesis that intraoperative and postoperative intravenous restrictive fluid regime reduces postoperative morbidity and mortality and improves the outcome of the treatment of minilaparotomy AAA repair.

详细描述

We investigate effects of a restricted fluid regime versus standard regimen on complications and hospital stay after minilaparatomy aortic aneurysm repair.

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

性别
All
接受健康志愿者

入选标准

  • AAA more than 5,5 cm in diameter tube graft

排除标准

  • emargency comorbidity maligancy

研究组 & 干预措施

Drag: Crystalloids and Colloids

Active Comparator

Drag: Crystalloids and Colloids Intraoperative 10 ml/kg/per hour, postoperative 70-100 ml/per hour

干预措施: Restrictive VS Standard Fluid Regime (Procedure)

结局指标

主要结局

Number of major and minor complications

时间窗: 30 days

次要结局

  • ICU and duration of Hospital stay(30 days)
  • In-hospital mortality, 30-days mortality(30 days)
  • Fluid balance (daily and cumulative)(3 days)

研究者

发起方
University Clinical Center Tuzla
申办方类型
Other
责任方
Sponsor

相似试验