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OpenTrials
Completed

NCT Number: NCT01627639

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

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.

Completed

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Key information

Conditions

Decompensated Chronic Obstructive Pulmonary Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Treatment and study plan

Acetazolamide

Drug

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

Drug

Placebo

Primary outcomes

  1. length of invasive mechanical ventilation

    Time frame: within the first 28 days after intubation

Secondary outcomes

  1. Length of weaning from mechanical ventilation

    Time frame: once at the extubation or at day 28

    data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy

  2. weaning success

    Time frame: once at the end of ICU stay or at Day 28

    Data collected once at the end of ICU stay or at Day 28

  3. numbers of nosocomial infections

    Time frame: every day during 28 days

    data retrieved every day, until extubation or at the end of invasive ventilation in the tracheotomy

  4. length of ICU stay

    Time frame: once at the end of ICU stay or at Day 28

    Data collected once at the end of ICU stay or at Day 28

  5. ICU mortality

    Time frame: once at the end of ICU stay or at Day 28

    Data collected once at the end of ICU stay or at Day 28

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: DIABOLO

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jun 26, 2012
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.