Use of IgM-enriched immunoglobulin mixture in severe burn patients

Use of IgM-enriched intravenous immunoglobulin mixture in patients with severe burn: a randomized placebo-controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085121

Enrollment

Registered

2025-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: T312- Burns involving 20-29% of body surface Health Condition 2: T313- Burns involving 30-39% of body surface Health Condition 3: T314- Burns involving 40-49% of body surface Health Condition 4: T315- Burns involving 50-59% of body surface

Interventions

Intervention1: IgM-enriched immunoglobulin infusion: 5 ml/kg ideal body weight of IgM-enriched intravenous immunoglobulin infusion daily on three consecutive days at a rate of 0.4 ml/Kg/hour starting

Eligibility

Inclusion criteria

Inclusion criteria: Patients with 20% -60% TBSA (Total Body Surface Area) burn

Exclusion criteria

Exclusion criteria: 1. Refusal to consent. 2. Patients with associated incurable metastatic malignant disease or unstable hematological malignancies, uncontrolled diabetics, cardiac diseases. 3. Patient is a known case of Hypersensitivity to human immunoglobulin, such as may occur in pathological immunoglobulin-G or immunoglobulin-A deficiencies. 4. Pregnant or Lactating females

Design outcomes

Primary

Measure	Time frame
MortalityTimepoint: at 30 days	—

Secondary

Measure	Time frame
Duration of stay in the ICUTimepoint: Till ICU discharge/death;Duration of stay in the hospitalTimepoint: Till discharge from hospital/death;Change in SOFA ScoreTimepoint: over 30 days;Vasopressor requirementTimepoint: over 30 days;Duration of mechanical ventilationTimepoint: within 30 days;Requirement of Renal Replacement Therapy (RRT)Timepoint: in 30 days	—

Countries

India

Contacts

Public ContactDr Shailendra Kumar

All India Institute Of Medical Sciences, New Delhi

drshail.kumar@gmail.com7003664307

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026