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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cortisteroids arm | Active Comparator |
| |
| placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the number of ventilator-free days (VFD) and alive at day 28. | To determine if the systemic 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. | day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| NIV failure rate | NIV failure rate, defined by intubation within day 7 | day 7 |
| Duration of NIV and of invasive mechanical ventilation | Duration of Non Invasive Ventilation and of invasive mechanical ventilation |
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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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| virginie chatagner | Contact | 0139239776 | vchatagner@ght78sud.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| André Mignot Hospital, Intensive care unit | Recruiting | Le Chesnay | Les Yvelines | 78150 | France |
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|
| Placebos | Drug | 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. |
|
| at day 90 |
| Circulatory and renal support-free days and alive at day 28 | Circulatory and renal support-free days and alive at day 28 | at day 28 |
| Severe hyperglycemia requiring intravenous insulin during the five first days | Severe hyperglycemia requiring intravenous insulin during the five first days | during the five first days |
| Gastro-intestinal bleeding | acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation | between inclusion and day 28 |
| Uncontrolled arterial hypertension | unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications) | between inclusion and day 28 |
| ICU acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge | Intensive Care Unit acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge | at day 28 |
| ICU-acquired infections (especially Ventilator-Associated Pneumonia) | Intensive Care Unit -acquired infections (especially Ventilator-Associated Pneumonia) | at the time of ICU discharge or day 90 |
| Length of ICU and hospital stay | Length of ICU and hospital stay | at day 90 |
| ICU and hospital mortality | ICU and hospital mortality | between inclusion and day 28 or day 90 |
| Day 28 and Day 90 mortality | Day 28 and Day 90 mortality | at Day 28 and Day 90 |
| Standardized mortality ratio (SMR) | Standardized mortality ratio (SMR) | between inclusion and day 90 |
| Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90 | Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90 | at day 90 |
| Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score | Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score | at day 90 |
| respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score | respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score | at day 90 |
| CHU Angers | Recruiting | Angers | France |
|
| CH métropole savoie | Not yet recruiting | Chambéry | France |
|
| CHU Louis Mourier | Recruiting | Colombes | France |
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| CHU Henri mondor | Not yet recruiting | Créteil | France |
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| CHU Dijon | Recruiting | Dijon | France |
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| CHU Grenoble | Recruiting | Grenoble | France |
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| CHD Vendée | Recruiting | La Roche-sur-Yon | France |
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| CHU de Bicêtre | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
|
| CH Le Mans | Recruiting | Le Mans | France |
|
| CHRU lille | Recruiting | Lille | France |
|
| CHU Lyon | Recruiting | Lyon | France |
|
| CH d'Annecy Genevois | Recruiting | Metz-Tessy | 74370 | France |
|
| CHU Nantes | Not yet recruiting | Nantes | France |
|
| CHR orléans | Recruiting | Orléans | France |
|
| CHU Cochin | Recruiting | Paris | France |
|
| Hôpital européen Georges pompidou | Recruiting | Paris | France |
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| Pitié-Salpêtrière | Recruiting | Paris | France |
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| CHU Poitiers | Recruiting | Poitiers | France |
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| CHU de Rennes | Recruiting | Rennes | France |
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| CHU de Rouen | Not yet recruiting | Rouen | France |
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| Hopital Foch | Active, not recruiting | Suresnes | France |
| CHRU Tours | Recruiting | Tours | France |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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