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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627639
First received: April 2, 2012
Last updated: April 11, 2014
Last verified: February 2012
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of weaning from mechanical ventilation [ Time Frame: once at the extubation or at day 28 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Data collected once at the end of ICU stay or at Day 28

  • numbers of nosocomial infections [ Time Frame: every day during 28 days ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Data collected once at the end of ICU stay or at Day 28


Estimated Enrollment: 380
Study Start Date: October 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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
Other Name: Acetazolamide
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Other Name: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01627639

Contacts
Contact: Gilles Chatellier, MD, PhD +33(0)156092026 gilles.chatellier@egp.aphp.fr
Contact: Chantal Andrieux, PhD 33(0)156095479 chantal.andrieux@egp.aphp.fr

Locations
France
Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris Recruiting
Paris, France, 75015
Contact: Gilles Chatellier, MD, PhD    +33(0)156092026    gilles.chatellier@egp.aphp.fr   
Contact: Chantal Andrieux, PhD    +33(0)156095479    chantal.andrieux@egp.aphp.fr   
Principal Investigator: Christophe Faisy, MD, PhD         
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:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01627639     History of Changes
Other Study ID Numbers: AOM09109
Study First Received: April 2, 2012
Last Updated: April 11, 2014
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Alkalosis
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Acid-Base Imbalance
Metabolic Diseases
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014