CORTICOP_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

Conditions

COPD : chronic obstructive Pulmonary disease

Brief summary

Number of ventilator-free days (VFD) and alive.

Detailed description

NIV failure rate, defined by intubation, Duration of NIV and of invasive mechanical ventilation, Circulatory support-free days and alive at day 28, Severe hyperglycemia requiring intravenous insulin before day 5, Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation, Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications), ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge, ICU-acquired infections (especially Ventilator-Associated Pneumonia), Length of ICU and hospital stay, ICU and hospital mortality, Day 28 and Day 90 mortality, Standardized mortality ratio (SMR), Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90, Dyspnea and comfort (patient reported outcome) at Day 90

Related papers

No related papers found yet.

Interventions

DRUGMETHYLPREDNISOLONE VIATRIS 120 mg

DRUGpoudre pour solution injectable (IM-IV)

DRUGSODIUM CHLORURE 0

DRUG9 % BIOLUZ

DRUGsolution injectable

DRUGpoche

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of ventilator-free days (VFD) and alive.	—

Secondary

Measure	Time frame
NIV failure rate, defined by intubation, Duration of NIV and of invasive mechanical ventilation, Circulatory support-free days and alive at day 28, Severe hyperglycemia requiring intravenous insulin before day 5, Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation, Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications), ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge, ICU-acquired infections (especially Ventilator-Associated Pneumonia), Length of ICU and hospital stay, ICU and hospital mortality, Day 28 and Day 90 mortality, Standardized mortality ratio (SMR), Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90, Dyspnea and comfort (patient reported outcome) at Day 90	—

Measure

Time frame

NIV failure rate, defined by intubation, Duration of NIV and of invasive mechanical ventilation, Circulatory support-free days and alive at day 28, Severe hyperglycemia requiring intravenous insulin before day 5, Gastro-intestinal bleeding: acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation, Uncontrolled arterial hypertension: unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications), ICU acquired weakness (MRC-score) assessed on day 28 or at the time of ICU discharge, ICU-acquired infections (especially Ventilator-Associated Pneumonia), Length of ICU and hospital stay, ICU and hospital mortality, Day 28 and Day 90 mortality, Standardized mortality ratio (SMR), Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90, Dyspnea and comfort (patient reported outcome) at Day 90

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Countries

France

Outcome results

None listed