Acute Lung Injury (ALI) - Acute Respiratory Distress Syndrome (ARDS) MedDRA version: 6.1 Level: PT Classification code 10049874
Conditions
Interventions
Trade Name: SOLUMEDROL*IM IV FL 40MG 1ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methylprednisolone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age. Patients age 18 years or older admitted to the intensive care unit. 2. ALI/ARDS criteria. The diagnosis of ALI/ARDS requires all of the following criteria: Respiratory failure requiring mechanical ventilation ? via endotracheal intubation or noninvasive positive pressure ventilation Acute onset of bilateral pulmonary densities on chest radiograph in the contest of appropriate predisposing injury or illness with no evidence of left ventricular failure, Static pulmonary compliance =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Failure to obtain written informed consent;trauma-induced ARDS;major gastrointestinal bleeding requiring transfusion of 5 units or more of packed red blood cells (PRBC) within 3 months current hospitalization;condition requiring > 0.5mg/Kg/day of prednisone equivalent (i.e., acute asthma or chronic obstructive pulmonary disease [COPD]);patients enrolled in another experimental (interventional) protocol within the past 30 days;pregnancy confirmed by urine or serum test; weight is > 200% of ideal body weight; immunosuppression including HIV+ status;severe chronic liver disease (Child-Pugh Class C score > 10 points)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of low-dose methilprednisolone infusion compared to placebo, on the incidence of all-cause 28 day mortality, defined as the proportion of patients alive in each group under study day 28 at midnight;Secondary Objective: to measure the hospital effects of low-dose methylprednisolone infusion compared to placebo: A. Systemic inflammation Resolution of systemic inflammation, defined as timing to a 50% reduction in Creactive protein level from study entry. 2B. Pulmonary and extra-pulmonary organ disfunction Reduction in duration of mechanical ventilation, defined as (a) mechanical ventilation-free days to day 28, and (b) duration of mechanical ventilation on day 28. Improvement in multiple organ dysfunction syndrome (MODS), defined as MODSfree days to day 28. Reduction in duration of intensive care unit (ICU) stay and hospital stay. Reduction in hospital cardiovascular morbidity-mortality, defined as acute myocardial ischemia-infarction, cerebrovascular accident (stroke), sudden (in the absence of vasopressor-dependent shock) cardiac event or death as a result of ventricular arrhythmia, myocardial ischemia-infarction, or stroke B. Complications;Primary end point(s): All-cause 28 day mortality, defined as the proportion of patients alive in each group under study day 28 at midnight | — |
Countries
Italy
Outcome results
None listed