Severe acute exacerbations of Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Trade Name: METHYLPREDNISOLONE
Pharmaceutical Form: Lyophilisate for solution for infusion
Pharmaceutical form of the placebo: Solution for injection/infusion
Route of administration of the placebo: I
Sponsors
Centre Hospitalier de Versailles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients aged = 40 years, man or woman 2) Strongly suspected or documented COPD defined by all the following criterias : - Persistent respiratory symptoms (dyspnoea, chronic cough or sputum production) - History of exposure to a risk factor such as tobacco smoke - If available, pulmonary function tests showing airflow limitation that is not fully reversible (post-bronchodilator ratio of forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: Patient will not be included if they present any of the following criteria 1) Previous diagnostic of asthma, according to “GINA” international guidelines 2) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days 3) Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding 4) Pneumothorax at randomization 5) Extracorporeal life support (ECMO or ECCO2R) at randomization 6) Moribund patient life expectancy < 3 months 7) Pregnancy 8) Patients protected by law 9) Exclusion period due to other clinical trial enrolment which can influence primary outcome 10) Previous inclusion in the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if the systemic administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.;Secondary Objective: Evaluate the effect of corticosteroids administration, as compared to placebo on : - mechanical ventilation and support - side effects of corticosteroids - lenght of stay - mortality - COPD exacerbations case ;Primary end point(s): Number of ventilator-free days (VFD) and alive.;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - NIV failure rate, defined by intubation - Duration of NIV and of invasive mechanical ventilation - Circulatory and renal support-free days and alive at day 28 - Severe hyperglycemia requiring intravenous insulin before day 5 - Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation - Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications) - ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge - ICU-acquired infections (especially Ventilator-Associated Pneumonia) - Length of ICU and hospital stay - ICU and hospital mortality - Day 28 and Day 90 mortality - Standardized mortality ratio (SMR) - Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90 - Dyspnea and comfort (patient reported outcome) at Day 90;Timepoint(s) of evaluation of this end point: - Day 5 - Day 7 - Day 28 - Time of ICU discharge - Day 90 after discharge | — |
Countries
France
Contacts
Public ContactLaure MORISSET
Centre Hospitalier de Versailles
Outcome results
None listed