Clinical trial NCT01627639: Effectiveness of Acetazolamide for Reversal of Metabolic Alkalosis in Mechanically Ventilated Chronic Obstructive Pulmonary Disease Patients
Official title: A Randomized Trial to Evaluate Effectiveness of Acetazolamide in COPD Patients Developing Metabolic Alkalosis During Invasive Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Decompensated Chronic Obstructive Pulmonary Disease
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-06-26
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Primary outcomes:
measure: length of invasive mechanical ventilation
timeFrame: within the first 28 days after intubation
Secondary outcomes:
measure: Length of weaning from mechanical ventilation
timeFrame: once at the extubation or at day 28
measure: weaning success
timeFrame: once at the end of ICU stay or at Day 28
measure: numbers of nosocomial infections
timeFrame: every day during 28 days
measure: length of ICU stay
timeFrame: once at the end of ICU stay or at Day 28
measure: ICU mortality
timeFrame: once at the end of ICU stay or at Day 28
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris
Study officials:
affiliation: Medical Intensive Care Unit, European Georges Pompidou Hospital, Asssistance Publique - Hôpitaux de Paris, Paris Descartes University, Paris, FRance
name: Christophe Faisy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.