Decompensated Chronic Obstructive Pulmonary Disease Clinical Trial
— DIABOLOOfficial title:
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Clinical Research Unit, European Georges Pompidou Hospital, Assistance Publique - Hôpitaux de Paris | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Ministry of Health, France |
France,
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
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 |