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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Decompensated Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Acetazolamide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetazolamide<br>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 | Drug: Acetazolamide<br>* 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<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of invasive mechanical ventilation |  | within the first 28 days after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of weaning from mechanical ventilation | data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy | once at the extubation or at day 28 | 
| weaning success | Data collected once at the end of ICU stay or at Day 28 | once at the end of ICU stay or at Day 28 | 
| numbers of nosocomial infections | data retrieved every day, until extubation or at the end of invasive ventilation in the tracheotomy | every day during 28 days | 
| length of ICU stay | Data collected once at the end of ICU stay or at Day 28 | once at the end of ICU stay or at Day 28 | 
| ICU mortality | Data collected once at the end of ICU stay or at Day 28 | once at the end of ICU stay or at Day 28 |