Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Burn Shock

Treatments: Drug: intravenous immunoglobulin

Study type: Interventional

Funder types: Other

Identifiers

NCT05134792

Pt 2221

Details and patient eligibility

About

Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.

Full description

After randomization, Treatment and control groups will receive Parkland formula (4 ml/kg per percent total burn surface area; (TBSA), counting moderate (partial thickness) and severe (full thickness) burn area only) using Ringer's lactate solution (half of the fluid will be given over the first eight hours and the remaining half will be given over the next 16 hours), plus normal 24-hour maintenance fluid requirements using glucose solution.

When initiating Parkland, treatment group (Group A) will receive intravenous immunoglobulin IVIG (LIV-GAMMA "S/D treated Human Immunoglobulin" 2.5 grams/50 ml) with a dose of 200 mg/kg once on admission.

• On each septic or septic shock episode in either groups, the patients will be treated with appropriate antibiotics empirically or culture-based.

  • Assessments
  • On admission, all patients included in the study will be fully examined clinically to identify the extent and area of burn and clinical signs of infection or dehydration as fever, respiratory rate, urinary output and capillary refill. Besides, non-invasive blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial blood pressure (MAP)), electrocardiogram and arterial oxygen saturation will be assessed.
  • Parameters to be measured

• Serum immunoglobulin G( IgG) level,

• Serum micro RNA (miR-25) ,

• Serum C reactive protein (CRP) level,

• Serum lactate,

• Serum Procalcitonin

• Serum Malondialdehyde(MDA).

• Serum Glutathione Peroxidase .

  • In addition, Complete Blood picture with differential, coagulation profile, liver function tests (alanine transaminase (ALT), aspartate amino transferase(AST), Albumin and Bilirubin), and kidney functions (Blood urea nitrogen (BUN) and serum creatinine) will be evaluated.

Pan cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

Enrollment: 30 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All burn patients 1 to 5 years old with 10% or greater burn area of TBSA .

Exclusion criteria

• Patients with septic shock (evidence of infection and inotropes) .
• Burns more than 48 hours duration.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

No intravenous immunoglobulin (IVIG)

No Intervention group

Description:

The control group are burn patients with inclusion criteria that did not receive IVIG.

Intravenous immunoglobulin (IVIG) group

Experimental group

Description:

Pediatric burn patients between 1and 5 years with 10% or greater burn area of TBSA within 24 hours of onset of burn will receive intravenous immunoglobulin.

Treatment:

Drug: intravenous immunoglobulin