Oral Prednisolone in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)
Recruitment status was: Recruiting
Evaluation of systematic administration of oral prednisolone (1mg/Kg/day) as an add on therapy in Chronic Obstructive Pulmonary Disease (COPD) patients admitted to intensive care unit (ICU) for severe exacerbation of COPD. Patients with pneumonia are excluded.
Randomization is stratified according to ventilatory support: non invasive or conventional ventilation.The major outcome is the ICU mortality rate in overall population and stratified according to ventilatory mode (noninvasive ventilation (NIV) versus conventional).
Secondary outcomes are superinfection necessitating a new antibiotic course, Length of mechanical ventilation (MV) (and ventilatory free days), Length of ICU stay, The frequency of gastric bleeding episodes that of frequency of hyperglycemic episodes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Prospective Randomized Trial of Systemic Corticosteroids (Oral Prednisolone) in Severe Exacerbation of COPD Requiring Ventilatory Assistance|
- ICU mortality rate [ Time Frame: ICU stay (on average patients will be followed 30 days) ] [ Designated as safety issue: Yes ]
- Length of MV (and ventilatory free days) [ Time Frame: ICU stay (on average patients will be followed 30 days) ] [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
No Intervention: usual care
patients will receive usual care
Drug: usual care
no drug administered
Active Comparator: Prednisolone
1mg/kg/day prednisolone for the entire ICU stay and a maximum of 10 days
Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353235
|Monastir, Tunisia, 5000|
|Principal Investigator:||Fekri Abroug, MD||CHU F.Bourguiba Monastir|