Prospective,Double-Blind Randomized Clinical Trial on the Effects of Early Administration of Prolonged Methylprednisolone Therapy in early Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS) - ND

Conditions: Acute Lung Injury (ALI) - Acute Respiratory Distress Syndrome (ARDS)
MedDRA version: 6.1Level: PTClassification code 10049874

Registration Number: EUCTR2007-005901-23-IT

Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

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 < 50 cm H2O
Ratio of partial pressure of arterial oxygen to partial pressure of alveolar oxygen
(PaO2:FiO2 ) equal or less than 300 (criteria for ALI) or 200 (criteria for ARDS)with FiO2 1.0.
3. Severe ARDS. PaO2:FiO2 equal or less than 200 after 30 minutes of standardized ventilatory management on PEEP of 10 cm H2O with FiO2 1.0.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)