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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01627639
First Posted: June 26, 2012
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention Phase
Decompensated Chronic Obstructive Pulmonary Disease Drug: Acetazolamide Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • length of invasive mechanical ventilation [ Time Frame: within the first 28 days after intubation ]

Secondary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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


Enrollment: 380
Study Start Date: October 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: 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 Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01627639


Locations
France
Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Principal Investigator: Christophe Faisy, MD, PhD Medical Intensive Care Unit, European Georges Pompidou Hospital, Asssistance Publique - Hôpitaux de Paris, Paris Descartes University, Paris, FRance
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01627639     History of Changes
Other Study ID Numbers: AOM09109
First Submitted: April 2, 2012
First Posted: June 26, 2012
Last Update Posted: October 6, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Alkalosis
Respiratory Tract Diseases
Acid-Base Imbalance
Metabolic Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs