Effect of steroids in critically ill children with high ferriti
Phase 4
- Conditions
- Health Condition 1: R652- Severe sepsis
- Registration Number
- CTRI/2024/08/072531
- Lead Sponsor
- ot applicable
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Moderate and severe hyperferritinemia (Ferritin more than 3000) and two organ dysfunctions (at least one of which is respiratory, cardiovascular, neurological or renal) who have persistent or worsening organ dysfunction after 48 hours of disease specific therapy
Exclusion Criteria
Rheumatological disorder, oncological disorder, corticosteroid or other immunosuppressive agents for 14 days or more, patients who already received 2mg/kg prednisolone or equivalent/IVIg/anakinra in the current illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Organ failure free daysTimepoint: DAY 28 After randomization
- Secondary Outcome Measures
Name Time Method 1.Mortality at 28 days <br/ ><br>2.Proportion of children requiring new organ support <br/ ><br>3.Length of PICU stay in survivors <br/ ><br>4.Adverse effects during therapy <br/ ><br>5.Decrease in serum ferritin levels at days 3 & 7 <br/ ><br>Timepoint: At day 3, 7, 28