跳至主要内容
临床试验/NCT03552601
NCT03552601Unknown不适用

The Effect of Negatively Fluid Balancing Speed for ICU Patients With Acute Respiratory Distress Syndrome

Qingdao University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
1
主要终点
increased oxygenation index proportion at 24h

研究概览

简要总结

Previous studies have shown that a positive fluid balance was an independent factor of worse prognosis in ICU patients with acute respiratory distress syndrome (ARDS), and negative fluid balance has been demonstrated to increase oxygenation index, reduce time under mechanical ventilation and ICU length of stay with no noticeable adverse effects. But there is no evidence that faster speed of negative fluid balance would be more beneficial for ARDS patients. So researchers designed the study to prove the effect of negatively fluid balancing speed for ICU patients with ARDS.

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 with ARDS (Berlin 2012 criterion)

排除标准

  • Pregnant women
  • Unstable hemodynamics status
  • < 18 years old

结局指标

主要结局

increased oxygenation index proportion at 24h

时间窗: at the time of 24 hours

Oxygenation index equals arterial oxygen partial pressure/fraction of inspiration O2 (PO2/FIO2). Increased oxygenation index proportion at 24h equals (oxygenation index at 24h - oxygenation index at baseline)/ oxygenation index at baseline.

次要结局

  • Duration of free mechanical ventilation(up to 28 days)
  • Oxygenation index every day(up to 7 days)
  • mortality(up to 28 days)

研究者

发起方
Qingdao University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bo Yao,phD

Clinician of intensive care unit, Principal Investigator

Qingdao University

研究点 (1)

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