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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01627639

Collaborator

Ministry of Health, France (Other)

380

Enrollment

Location

Arms

Duration (Months)

11.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Decompensated Chronic Obstructive Pulmonary Disease	Drug: Acetazolamide Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Placebo	Drug: Placebo Placebo

Arm

Intervention/Treatment

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

Placebo Comparator: Placebo

Placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

length of invasive mechanical ventilation [within the first 28 days after intubation]

Secondary Outcome Measures

Length of weaning from mechanical ventilation [once at the extubation or at day 28]
data retrieved once, at the extubation or at the end of invasive ventilation in the tracheotomy
weaning success [once at the end of ICU stay or at Day 28]
Data collected once at the end of ICU stay or at Day 28
numbers of nosocomial infections [every day during 28 days]
data retrieved every day, until extubation or at the end of invasive ventilation in the tracheotomy
length of ICU stay [once at the end of ICU stay or at Day 28]
Data collected once at the end of ICU stay or at Day 28
ICU mortality [once at the end of ICU stay or at Day 28]
Data collected once at the end of ICU stay or at Day 28

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Decompensated COPD on invasive mechanical ventilation Less than 24 hours

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris	Paris		France	75015

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