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

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

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cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

Official Title
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Effect of Pre-emptive Intravenous Immunoglobulin Administration on the Incidence of Septic Episodes in Pediatric Burn Patients: A Randomized Controlled Study

Conditions
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Burn Shock

Intervention / Treatment
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* Drug: intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intravenous immunoglobulin (IVIG)<br>The control group are burn patients with inclusion criteria that did not receive IVIG. | |
| Experimental: Intravenous immunoglobulin (IVIG) group<br>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. | Drug: intravenous immunoglobulin<br>* All pediatric burn patients allocated in group intra venous immunoglobulin admitted will receive 200 mg/kg IVIG once after their initial resuscitation before 48 hours passes of burn incident.<br>* Other names: LIV GAMMA S/D treated Human Immunoglobulin 2.5 grams/50 ml;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sepsis during ICU stay will be recorded. | Sepsis is defined by clinical criteria (temperature more than 38.9 °C, leukocytosis, thrombocytopenia, glucose intolerance, and/or new onset of ileus) and/or the presence of a positive blood culture in association with clinical signs of infection/sepsis. An increase in Procalcitonin level will be also used as an early laboratory marker for sepsis. | Through out study completion, average 30 days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of septic shock | Defined by evidence of sepsis as previously mentioned and need for inotropes to support circulation. | Through out study completion, average 30 days. | 
| Number of septic episodes | Sepsis is defined by clinical criteria (temperature more than 38.9 °C, leukocytosis, thrombocytopenia, glucose intolerance, and/or new onset of ileus) and/or the presence of a positive blood culture in association with clinical signs of infection/sepsis. | Throughout the study completion average 30 days. | 
| Length of stay | days | Through out study completion, average 30 day. | 
| PEdiatric Logistic Organ Dysfunction score 2 (PELOD-2) | Clinical assessment score used as diagnostic and prognostic tool of sepsis in pediatrics.It includes cardiovascular, neurologic, respiratory, hematologic, renal dysfunctions assessment adjusted to age.A higher PELOD-2 score correlates with a higher number of organ failures and mortality rate incidence.Each measurement gives a score form 0 to 6 and total score is directly proportional to increased morbidity and mortality probability. | Through out study completion, average 30 days | 
| Mortality rate | Number of patients | 30 days | 
| Days of mechanical ventilation | days | From date of randomization until the date of first documented progression or date of death from any cause, |