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

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

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.

Study Overview

• Status: Completed
• Conditions: Decompensated Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Placebo; Drug: Acetazolamide

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.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
length of invasive mechanical ventilation	within the first 28 days after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of weaning from mechanical ventilation	data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy	once at the extubation or at day 28
weaning success	Data collected once at the end of ICU stay or at Day 28	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	every day during 28 days
length of ICU stay	Data collected once at the end of ICU stay or at Day 28	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	once at the end of ICU stay or at Day 28

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 2, 2012
• First Submitted That Met QC Criteria: June 21, 2012
• First Posted (Estimate): June 26, 2012

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Respiratory Tract Diseases; Acid-Base Imbalance; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Alkalosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Natriuretic Agents; Diuretics; Anticonvulsants; Acetazolamide
• Other Study ID Numbers: AOM09109

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No