Informations générales (source: ClinicalTrials.gov)
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 (Corticop)
Interventional
Phase 3
Versailles Hospital (Voir sur ClinicalTrials)
octobre 2021
mars 2026
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Benjamin Zuber | 21/10/2024 07:07:13 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Europeen Georges Pompidou | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Louis Mourier | Contact (sur clinicalTrials) | ||||
| CH DE VERSAILLES SITE ANDRE MIGNOT | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH d'Annecy Genevois - 74370 - Metz-Tessy - France | Contact (sur clinicalTrials) | ||||
| CH métropole savoie - Chambéry - France | Contact (sur clinicalTrials) | ||||
| CHD Vendée - La Roche-sur-Yon - France | Contact (sur clinicalTrials) | ||||
| CHR orléans - Orléans - France | Contact (sur clinicalTrials) | ||||
| CHRU Tours - Tours - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen - Rouen - France | Contact (sur clinicalTrials) | ||||
| CHU Dijon - Dijon - France | Contact (sur clinicalTrials) | ||||
| CHU Lyon - Lyon - France | Contact (sur clinicalTrials) | ||||
| CHU Poitiers - Poitiers - France | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Le Mans - Le Mans - France | Contact (sur clinicalTrials) | ||||
| CHU Angers - Angers - France | Contact (sur clinicalTrials) | ||||
| CHU de Bicêtre - 94270 - Le Kremlin-Bicêtre - France | Contact (sur clinicalTrials) | ||||
| CHU Grenoble - Grenoble - France | Contact (sur clinicalTrials) | ||||
| CHU Henri mondor - Créteil - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital Foch - Suresnes - France | Contact (sur clinicalTrials) | ||||
| Pitié-Salpêtrière - Paris - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Patients aged ≥ 40 years
2. Strongly suspected or documented COPD, defined by the presence of the following
criterias:
- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
- History of exposure to a risk factor such as tobacco smoke
- If available, pulmonary function tests showing airflow limitation not fully
reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7)
3. ACRF, defined by the presence of the two following criteria:
- COPD exacerbation defined by a change in the patient baseline respiratory
symptoms at least 24 hours and requiring a change in regular respiratory
medication
- Acute respiratory failure <24h (polypnea ≥ 30 breaths.min-1 or use of accessory
respiratory muscles) requiring ventilatory support, either invasive
(implemented because of respiratory distress) or NIV (implemented because of
hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
4. Admission to an ICU, a step-up unit or a respiratory care unit
5. 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.
6. Affiliation to (or benefit from) French health insurance system
1. Patients aged ≥ 40 years
2. Strongly suspected or documented COPD, defined by the presence of the following
criterias:
- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
- History of exposure to a risk factor such as tobacco smoke
- If available, pulmonary function tests showing airflow limitation not fully
reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7)
3. ACRF, defined by the presence of the two following criteria:
- COPD exacerbation defined by a change in the patient baseline respiratory
symptoms at least 24 hours and requiring a change in regular respiratory
medication
- Acute respiratory failure <24h (polypnea ≥ 30 breaths.min-1 or use of accessory
respiratory muscles) requiring ventilatory support, either invasive
(implemented because of respiratory distress) or NIV (implemented because of
hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
4. Admission to an ICU, a step-up unit or a respiratory care unit
5. 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.
6. Affiliation to (or benefit from) French health insurance system
- Previous diagnostic of asthma, according to "GINA" international guidelines (40)
- Recent use of systemic corticosteroids, defined by systemic corticosteroids use in
the past 7 days
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids,
uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus,
gastro-intestinal ulcer bleeding
- Pneumothorax at randomization
- Extracorporeal life support (ECMO or ECCO2R) at inclusion
- Moribund patient life expectancy < 3 months
- Pregnancy
- Patients protected by law
- Exclusion period due to other interventional clinical trial enrolment which can
influence primary outcome
- Previous inclusion in the present study