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

Decompensated Chronic Obstructive Pulmonary Disease Clinical Trial

— DIABOLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01627639
• Other study ID #: AOM09109
• Status: Completed
• Phase: Phase 4
• First received: April 2, 2012
• Last updated: October 5, 2015
• Start date: October 2011
• Est. completion date: July 2014

Study information

• Verified date: October 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decompensated Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• Placebo
Placebo

Locations

Country	Name	City	State
France	Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Chang WT, Thayer DW. The cellulase system of a Cytophaga species. Can J Microbiol. 1977 Sep;23(9):1285-92. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of invasive mechanical ventilation		within the first 28 days after intubation	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes