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

Primary Purpose

Decompensated Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetazolamide

Placebo

Arm Description

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

Outcomes

Primary Outcome Measures

length of invasive mechanical ventilation

Secondary Outcome Measures

Length of weaning from mechanical ventilation
data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy
weaning success
Data collected 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
length of ICU stay
Data collected 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

Full Information

First Posted
April 2, 2012
Last Updated
October 5, 2015
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01627639
Brief Title
Effectiveness of Acetazolamide for Reversal of Metabolic Alkalosis in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Acronym
DIABOLO
Official Title
A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
length of invasive mechanical ventilation
Time Frame
within the first 28 days after intubation
Secondary Outcome Measure Information:
Title
Length of weaning from mechanical ventilation
Description
data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy
Time Frame
once at the extubation or at day 28
Title
weaning success
Description
Data collected once at the end of ICU stay or at Day 28
Time Frame
once at the end of ICU stay or at Day 28
Title
numbers of nosocomial infections
Description
data retrieved every day, until extubation or at the end of invasive ventilation in the tracheotomy
Time Frame
every day during 28 days
Title
length of ICU stay
Description
Data collected once at the end of ICU stay or at Day 28
Time Frame
once at the end of ICU stay or at Day 28
Title
ICU mortality
Description
Data collected once at the end of ICU stay or at Day 28
Time Frame
once at the end of ICU stay or at Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Decompensated COPD on invasive mechanical ventilation Less than 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Faisy, MD, PhD
Organizational Affiliation
Medical Intensive Care Unit, European Georges Pompidou Hospital, Asssistance Publique - Hôpitaux de Paris, Paris Descartes University, Paris, FRance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21917139
Citation
Heming N, Faisy C, Urien S. Population pharmacodynamic model of bicarbonate response to acetazolamide in mechanically ventilated chronic obstructive pulmonary disease patients. Crit Care. 2011;15(5):R213. doi: 10.1186/cc10448. Epub 2011 Sep 14.
Results Reference
background
PubMed Identifier
20217
Citation
Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92. doi: 10.1139/m77-192.
Results Reference
background
PubMed Identifier
26836730
Citation
Faisy C, Meziani F, Planquette B, Clavel M, Gacouin A, Bornstain C, Schneider F, Duguet A, Gibot S, Lerolle N, Ricard JD, Sanchez O, Djibre M, Ricome JL, Rabbat A, Heming N, Urien S, Esvan M, Katsahian S; DIABOLO Investigators. Effect of Acetazolamide vs Placebo on Duration of Invasive Mechanical Ventilation Among Patients With Chronic Obstructive Pulmonary Disease: A Randomized Clinical Trial. JAMA. 2016 Feb 2;315(5):480-8. doi: 10.1001/jama.2016.0019.
Results Reference
derived

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

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