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Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
Sponsor: Versailles Hospital
Summary
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 acute on chronic respiratory failure (ACRF) requiring ventilatory support, either invasive or non-invasive.
Official title: Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2021-10-25
Completion Date
2025-04-17
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Methylprednisolone
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.
Placebos
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.
Locations (23)
CHU de Bicêtre
Le Kremlin-Bicêtre, France, France
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, France
CHU Angers
Angers, France
CH Argenteuil
Argenteuil, France
CH métropole savoie
Chambéry, France
CHU Louis Mourier
Colombes, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
CHD Vendée
La Roche-sur-Yon, France
CH Le Mans
Le Mans, France
CHRU lille
Lille, France
CHU Lyon
Lyon, France
CH d'Annecy Genevois
Metz-Tessy, France
CHU Nice
Nice, France
CHR orléans
Orléans, France
CHU Cochin
Paris, France
Hôpital européen Georges pompidou
Paris, France
Pitié-Salpêtrière
Paris, France
CHU Poitiers
Poitiers, France
CHU de Rennes
Rennes, France
Hopital Foch
Suresnes, France
CHRU Tours
Tours, France
CH Vannes
Vannes, France