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Immunoglobin therapy in burn sepsis

USE OF IV IMMUNOGLOBULIN MIXTURE IN THE TREATMENT OF BURN SEPSIS: A RANDOMIZED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056013
Enrollment
50
Registered
2023-08-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: IV IgM enriched Immunoglobin Mixture: 5 ml/kg body weight daily on three consecutive days. Infusion rate will be: 0.4 ml/kg/hour on day 7,8 and 9. Control Intervention1: fluids like rin

Sponsors

all india institute of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with >20% -60% TBSA thermal flame burn area with >18 years and 2.Septic shock markers: serum lactate >4 mmol/L and arterial pressure of 3.Persistence of septic shock with =2 organ dysfunctions after initial resuscitation treatment

Exclusion criteria

Exclusion criteria: 1.Refusal to consent. 2.Patients with associated incurable metastatic malignant disease or unstable hematological malignancies, 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.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of IV IgM enriched Immunoglobin Mixture in reducing the mortality of patients with burn sepsis within 30 days.Timepoint: 30 days.

Secondary

MeasureTime frame
1.To determine the effect of IV IgM enriched Immunoglobin Mixture in reducing the Duration of stay in the ICU & hospital stay. 2.To determine the effect of IV IgM enriched Immunoglobin Mixture in Changing the MOF (multiple organ failure) scores 3.To determine the effect of IV IgM enriched Immunoglobin Mixture on the requirement of catecholamine therapy 4.To determine the effect of IV IgM enriched Immunoglobin Mixture on the duration of artificial ventilation Timepoint: 30 days

Countries

India

Contacts

Public ContactShailendra Kumar

all india institute of medical sciences, New Delhi

drshail.kumar@gmail.com8745027472

Outcome results

None listed

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