EUCTR2019-001726-99-FRActive, not recruitingPhase 1
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. - CORTICOP
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 440
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1) Patients aged = 40 years, man or woman
- •2) Strongly suspected or documented COPD defined by all the following criterias :
- •- Persistent respiratory symptoms (dyspnoea, chronic cough or sputum production)
- •- History of exposure to a risk factor such as tobacco smoke
- •- If available, pulmonary function tests showing airflow limitation that is not fully reversible (post-bronchodilator ratio of forced expiratory volume in 1 s (FEV1)/forced vital capacity (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: dyspnoea, cough or sputum (volume or purulence) for at least 24 hours and requiring a change in regular respiratory medication
- •- Acute respiratory failure (defined by clinical signs of excessive muscle activity: polypnea = 30 breaths /min 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)
- •- Acute respiratory failure < 24h
- •4) Admission to an ICU, a step-up unit or a respiratory care unit
- •5) Written Informed consent from the patient or his surrogates. In patients who are not able to consent on admission (i.e., because of hypercapnic encephalopathy) and in absence of a substitute decision maker, an emergency inclusion procedure will be allowed, with a mandatory delayed consent
- •6) Affiliation to (or benefit from) French health insurance system.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 130
Exclusion Criteria
- •Patient will not be included if they present any of the following criteria
- •1) Previous diagnostic of asthma, according to GINA” international guidelines
- •2) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
- •3) Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- •4) Pneumothorax at randomization
- •5) Extracorporeal life support (ECMO or ECCO2R) at randomization
- •6) Moribund patient life expectancy < 3 months
- •7) Pregnancy
- •8) Patients protected by law
- •9) Exclusion period due to other clinical trial enrolment which can influence primary outcome
- •10) Previous inclusion in the present study.
Investigators
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