Effectiveness of Acetazolamide for Reversal of Metabolic Alkalosis in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients (DIABOLO)
This study is currently recruiting participants.
Verified February 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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: June 21, 2012
Last verified: February 2012
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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 2013 |
| Estimated Primary Completion Date: | November 2013 (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
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: | June 21, 2012 |
| 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 June 18, 2013