A comparative, randomised controlled trial for evaluating the efficacy of dexamethasone administration in the treatment of patients with the Acute Respiratory Distress Syndrome

INTERVENTION: Product Name: Dexametasona Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone CAS Number: 50‐02‐2 Other descriptive name: DEXAMETHASONE CONDITION: Acute respiratory distress syndrome (ARDS) ; MedDRA version: 14.1 Level: PT Classification code 10001052 Term: Acute respiratory distress syndrome System Organ Class: 10038738 ‐ Respiratory, thoracic and mediastinal disorders Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: To evaluate the efficacy of dexamethasone in increasing by the number of ventilator‐free days days (VFDs) at 28 days Primary end point(s): Number of ventilator free‐days (VFDs) at Day 28 (defined as days alive and free from mechanical ventilation at day 28 after intubation. For subjects ventilated >=28 days and for subjects who die, VFD is 0. Secondary Objective: To evaluate the efficacy of dexamethasone in reducing overall mortality. Timepoint(s) of evaluation of this end point: 60 days after discharge SECONDARY OUTCOME: Secondary end point(s): ‐All‐cause mortality at Day 60 after enrolment.; ‐Mortality at ICU and hospital discharge; ‐Duration (in days) on mechanical ventilation; ‐Number of extra‐pulmonary organ failures (we will consider central nervous system, heart, kidney, gastrointestinal, liver, coagulation, and shock). Timepoint(s) of evaluation of this end point: 60 days after discharge INCLUSION CRITERIA: To be eligible for inclusion into this study (Day 0), each patient must fulfil the following inclusion criteria during screening and prior to the enrolment into the study: a. Age >=18 years old b. Patients must have acute onset of ARDS, as defined by the American‐European Consensus Conference (AECC) criteria for ARDS: i. Having an initiating clinical condition (pneumonia, aspiration, inhalation injury, sepsis, trauma, acute pancreatitis, etc.). ii. bilateral infiltrates on frontal chest radiograph iii. absence of left atrial hypertension, a pulmonary capillary wedge pressure (PCWP) less than 18 mm Hg, or no clinical signs of left heart failure iv. severe hypoxemia (a PaO2/FIO2 <=200 mm Hg, regardless of FIO2 or positive end‐expiratory pressure (PEEP) c. Be intubated and mechanically ventilated d. Have provided signed written informed consent from the patient or the patient's personal legal representative. Are the trial subjects und