Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
NCT ID: NCT04163536
Last Updated: 2023-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
440 participants
INTERVENTIONAL
2021-10-25
2026-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Targeted Steroids for ARDS Due to COVID-19 Pneumonia: A Pilot Randomized Clinical Trial
NCT04360876
Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia
NCT04344730
Low Versus High Corticosteroid Use in Ventilator Associated Pneumonia
NCT04467892
Effects in Oxygenation and Hypoxic Pulmonary Vasoconstriction in ARDS Secondary to SARS-CoV2
NCT04998253
Impact of Dyspnea on Patients in the Intensive Care Unit
NCT02336464
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
cortisteroids arm
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.
placebo arm
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Versailles Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alexis FERRE
coordinating investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, France
CHU Angers
Angers, , France
CH métropole savoie
Chambéry, , France
CHU Louis Mourier
Colombes, , France
CHU Henri mondor
Créteil, , France
CHU Dijon
Dijon, , France
CHU Grenoble
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
CHU de Bicêtre
Le Kremlin-Bicêtre, , France
CH Le Mans
Le Mans, , France
CHRU lille
Lille, , France
CHU Lyon
Lyon, , France
CH d'Annecy Genevois
Metz-Tessy, , France
CHU Nantes
Nantes, , 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
CHU de Rouen
Rouen, , France
Hopital Foch
Suresnes, , France
CHRU Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P17/15_corticop
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.