Identification of best corticosteroid therapy for Acute Respiratory Distress Syndrome
- Conditions
- Health Condition 1: J80- Acute respiratory distress syndrome
- Registration Number
- CTRI/2022/02/039954
- Lead Sponsor
- Department of Science and Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 <br/ ><br> <br/ ><br>Utility outcome will be measured in terms of quality of life <br/ ><br>using EQ-5D and SGRQ scaleTimepoint: 7-days, 14-days, 28-days, 60 days and 90 days
- Secondary Outcome Measures
Name Time Method Treatment related ADRTimepoint: 7-days, 14-days, 28-days, 60 days and 90 days