UnknownPhase 3

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

France440 participantsStarted 2021-10-25

Plain-language 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 ACRF requiring ventilatory support, either invasive or non-invasive.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Patients aged ≥ 40 years
✓. Strongly suspected or documented COPD, defined by the presence of the following criterias:
✓. ACRF, defined by the presence of the two following criteria:
✓. Admission to an ICU, a step-up unit or a respiratory care unit
✓. Inform consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent.
✓. Affiliation to (or benefit from) French health insurance system

What they're measuring

the number of ventilator-free days (VFD) and alive at day 28.

Timeframe: day 28

Trial details

NCT IDNCT04163536

SponsorVersailles Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-25

Contact for this trial

virginie chatagner

0139239776 vchatagner@ght78sud.fr

View on ClinicalTrials.gov More Chronic Obstructive Pulmonary Disease trials