Effectiveness of Acetazolamide for Reversal of Metabolic Alkalosis in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients

Phase 4

Completed

• Conditions: Decompensated Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Acetazolamide; Drug: Placebo

• Registration Number: NCT01627639
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-06-21
• Study First Posted: 2012-06-26
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide	Acetazolamide	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
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
length of invasive mechanical ventilation	within the first 28 days after intubation

Secondary Outcome Measures

Name	Time	Method
numbers of nosocomial infections	every day during 28 days	data retrieved every day, until extubation or at the end of invasive ventilation in the tracheotomy
length of ICU stay	once at the end of ICU stay or at Day 28	Data collected once at the end of ICU stay or at Day 28
ICU mortality	once at the end of ICU stay or at Day 28	Data collected 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	data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy
weaning success	once at the end of ICU stay or at Day 28	Data collected once at the end of ICU stay or at Day 28

Trial Locations

Locations (1)

Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris; 🇫🇷 Paris, France