Effect of steroids in critically ill children with high ferritin

Effect of methylprednisolone in hyperferritinemic sepsis in children: a double blind randomized controlled trial (FERRIMED trial) - FERRIMED

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/08/072531

Enrollment

172

Registered

2024-08-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R652- Severe sepsis

Interventions

Intervention1: Methylprednisolone: Methylprednisolone 10mg/kg for 3 days Control Intervention1: Placebo- Normal saline: Normal saline infusion given 2ml/kg over 1 hour for 3 days

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Organ failure free daysTimepoint: DAY 28 After randomization	—

Secondary

Measure	Time frame
1. Mortality at 28 days 2. Proportion of children requiring new organ support 3. Length of PICU stay in survivors 4. Adverse effects during therapy 5. Decrease in serum ferritin levels at days 3 & 7 Timepoint: At day 3, 7, 28	—

Countries

India

Contacts

Public ContactDr Aakash Chandran C

PGIMER

mjshree@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026