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COMPLETED
NCT04163536
PHASE3

Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU

Sponsor: Versailles Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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