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临床试验/NCT01627639
NCT01627639已完成4 期

A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2011年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
380
试验地点
1
主要终点
length of invasive mechanical ventilation

研究概览

简要总结

The purpose of this study is to determine whether acetazolamide are effective to reduce the length of mechanical ventilation in decompensated Chronic Obstructive Pulmonary Disease (COPD) patients developing pure or mixed metabolic alkalosis.

详细描述

The purpose of this study is to determine whether acetazolamide is effective to reduce the length of mechanical ventilation in decompensated COPD patients developing pure or mixed metabolic alkalosis.

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
Quadruple (Participant, Care Provider, 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

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours

排除标准

  • 未提供

研究组 & 干预措施

Acetazolamide

Active Comparator

Acetazolamide (1 g IV per day or 2 g IV per day if coprescription of loop diuretics) or Placebo (saline serum) when pure or mixed metabolic alkalosis being present until planned extubation

干预措施: Acetazolamide (Drug)

Placebo

Placebo Comparator

Placebo

干预措施: Placebo (Drug)

结局指标

主要结局

length of invasive mechanical ventilation

时间窗: within the first 28 days after intubation

次要结局

  • numbers of nosocomial infections(every day during 28 days)
  • length of ICU stay(once at the end of ICU stay or at Day 28)
  • ICU mortality(once at the end of ICU stay or at Day 28)
  • Length of weaning from mechanical ventilation(once at the extubation or at day 28)
  • weaning success(once at the end of ICU stay or at Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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