Health Condition 1: J80- Acute respiratory distress syndrome
Conditions
Interventions
Intervention1: Dexamethasone and Budesonide: Intravenous Dexamethasone 20 mg once daily from days 1 to 5 followed by 10 mg once daily from days 6 to 10 and Budesonide nebulization at a dose of 2 mg ev
Sponsors
All India Institute of Medical Sciences AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Intubated and mechanically ventilated patients within 72 hours of a diagnosis of moderate – severe ARDS as defined by Berlin criteria of any cause.
Exclusion criteria
Exclusion criteria: 1.Already on steroid therapy/ immunosuppressive agents 2.C/I for steroid therapy 3.Pregnancy 4.Active lactation 5.Enrolment in other experimental study 6.Severe COPD 7.Congestive heart failure 8.Morbid obesity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean lung injury score from days 1 to 7Timepoint: Days 1 to 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers IL-6 and CRPTimepoint: Days 0,3,7 and 10;Number of prone sessionsTimepoint: Days 0 to 10;PaO2/FiO2 ratio, Plateau pressure, PaCO2, oxygenation index and mean blood glucose levelsTimepoint: Days 0 to 10;Sequential organ failure assessment scoreTimepoint: Days 0 to 10;Ventilator free days at Day 28 after randomization Timepoint: Day 28 after randomisation | — |
Countries
India
Contacts
Public ContactDr Vimi Rewari
All India Institute of Medical Sciences, New Delhi.
Outcome results
None listed