Health Condition 1: J80- Acute respiratory distress syndrome
Conditions
Interventions
None listed
Sponsors
Department of Science and Technology
Eligibility
Inclusion criteria
Inclusion criteria: Phase 1, 2a, and 3: All patients diagnosed with ARDS during the study period in Kasturba Hospital Manipal irrespective of age and gender. American/European Consensus Conference (AECC) criteria or Berlin Criteria for ARDS will be used to confirm the diagnosis of ARDS which includes the insult within 7 days duration; PaO2/FiO2 ratio of =200; the presence of bilateral infiltrates on chest radiograph and nonappearance of cardinal signs of left heart failure. Phase 2b: Healthcare physician with a minimum of 10 years experience in the management of ARDS
Exclusion criteria
Exclusion criteria: Phase 1, 2a, and 3: Patients with co-morbid illnesses like Human Immunodeficiency Virus positive, history of bone marrow or solid organ transplantation, current malignancy, receiving cytotoxic therapy for any reason, and concurrent steroid therapy; Any patient who is allergic or contraindicated to the corticosteroid therapy Phase 2b: Participant who is not willing to participate or not ready to give a signed informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Effectiveness assessed by using validated treatment effectiveness assessment tool which includes recovery/mortality, ventilator stay, ICU stay, hospital stay, and improvement in APACHE-II, SOFA, and LIS score Utility outcome will be measured in terms of quality of life using EQ-5D and SGRQ scaleTimepoint: 7-days, 14-days, 28-days, 60 days and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment related ADRTimepoint: 7-days, 14-days, 28-days, 60 days and 90 days | — |
Countries
India
Contacts
Public ContactDr Girish Thunga
Manipal Academy of Higher Education
Outcome results
None listed