The main objective of this study is to determine if the systemic (intravenous) 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
In the experimental group, methylprednisolone will be administered intravenously for 5 days at a dose of 1 mg/kg/day. Methylprednisolone will be provided for reconstitution and dilution in 50 ml of NaCl 0.9% solution and administered over 15 minutes, once a day.
in the control group, placebo will be administered intravenously for 5 days. Placebo will be identical (color and aspect) to experimental substance, will be provide as a 50 mL of NaCl 0.9% solution and administered intravenously over 15 minutes, once a day.
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, France
RECRUITINGthe number of ventilator-free days (VFD) and alive at day 28.
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.
Time frame: day 28
NIV failure rate
NIV failure rate, defined by intubation within day 7
Time frame: day 7
Duration of NIV and of invasive mechanical ventilation
Duration of Non Invasive Ventilation and of invasive mechanical ventilation
Time frame: at day 90
Circulatory and renal support-free days and alive at day 28
Circulatory and renal support-free days and alive at day 28
Time frame: at day 28
Severe hyperglycemia requiring intravenous insulin during the five first days
Severe hyperglycemia requiring intravenous insulin during the five first days
Time frame: during the five first days
Gastro-intestinal bleeding
acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
Time frame: between inclusion and day 28
Uncontrolled arterial hypertension
unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
Time frame: between inclusion and day 28
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CHU Angers
Angers, France
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Chambéry, France
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Colombes, France
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Créteil, France
NOT_YET_RECRUITINGCHU Dijon
Dijon, France
RECRUITINGCHU Grenoble
Grenoble, France
RECRUITINGCHD Vendée
La Roche-sur-Yon, France
RECRUITINGCHU de Bicêtre
Le Kremlin-Bicêtre, France
RECRUITINGCH Le Mans
Le Mans, France
RECRUITING...and 13 more locations
ICU acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
Intensive Care Unit acquired weakness (MRC-score \< 48/60) assessed on day 28 or at the time of ICU discharge
Time frame: at day 28
ICU-acquired infections (especially Ventilator-Associated Pneumonia)
Intensive Care Unit -acquired infections (especially Ventilator-Associated Pneumonia)
Time frame: at the time of ICU discharge or day 90
Length of ICU and hospital stay
Length of ICU and hospital stay
Time frame: at day 90
ICU and hospital mortality
ICU and hospital mortality
Time frame: between inclusion and day 28 or day 90
Day 28 and Day 90 mortality
Day 28 and Day 90 mortality
Time frame: at Day 28 and Day 90
Standardized mortality ratio (SMR)
Standardized mortality ratio (SMR)
Time frame: between inclusion and day 90
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Time frame: at day 90
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time frame: at day 90
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time frame: at day 90