Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.
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cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
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.
Cairo University
Cairo, Egypt
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.
Time frame: Through out study completion, average 30 days.
Incidence of septic shock
Defined by evidence of sepsis as previously mentioned and need for inotropes to support circulation.
Time frame: 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.
Time frame: Throughout the study completion average 30 days.
Length of stay
days
Time frame: 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.
Time frame: Through out study completion, average 30 days
Mortality rate
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Number of patients
Time frame: 30 days
Days of mechanical ventilation
days
Time frame: From date of randomization until the date of first documented progression or date of death from any cause,