Health Condition 1: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Conditions
Interventions
Intervention1: Eosinophil guided corticosteroid therapy group (EGT): Inj. Hydrocortisone 200 mg will be given on Day 1. Therafter,
Based on eosinophil count, patient will receive Inj. Hydrocortisone
Sponsors
All India Institute of Medical Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Clinician diagnosed COPD, and hospitalised due to AECOPD 2. Moderate to severe AECOPD diagnosis as defined by GOLD guidelines 2024, including those requiring HFNC, NIV or IMV 3. Signed informed consent
Exclusion criteria
Exclusion criteria: Known diagnosis of bronchial asthma Use of systemic corticosteroids for more than one week in the last 12 weeks More than 36 hours of systemic steroid usage during the current exacerbation Patients fit for discharge within 24 hours of admission or emergency visit Those with contraindications to systemic steroids, or those requiring systemic steroids for alternate indications such as adrenal insufficiency Pregnancy or lactation, severe mental illness Other systemic causes of eosinophilia Recent or current myocardial infarction Active pulmonary tuberculosis Post-tubercular or post-infective obstructive pulmonary disease with extensive scarring sequelae Active malignancy Systemic fungal infections Septic shock Life expectancy of less than 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of treatment success in the combination (Eosinophil guided systemic steroid plus high dose inhaled corticosteroid) arm therapy as compared to daily systemic corticosteroid therapy on Day 14Timepoint: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of adverse outcomes (Mortality , Prolonged hospital/ICU stay, ,COPD re-exacerbation leading to ER visits, re-admittance to hospitalTimepoint: Day 14 and 28;Length of ICU and hospital stayTimepoint: Day of Transfer out of ICU Day of discharge From randomisation;All-cause mortality rateTimepoint: Day 28 and Day 90;Cumulative corticosteroid dosageTimepoint: baseline, Day 14, and Day 28 | — |
Countries
India
Contacts
Public ContactDr Kartikeya Kumar Sharma
All India Institute of Medical Sciences
Outcome results
None listed