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

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

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

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cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

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.

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.

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.

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.

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.

From date of randomization until the date of first documented progression or date of death from any cause,

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.

Galal NM. Pattern of intravenous immunoglobulins (IVIG) use in a pediatric intensive care facility in a resource limited setting. Afr Health Sci. 2013 Jun;13(2):261-5. doi: 10.4314/ahs.v13i2.9.

Lyons JM, Davis C, Rieman MT, Kopcha R, Phan H, Greenhalgh D, Palmieri T, Kagan R. Prophylactic intravenous immune globulin and polymixin B decrease the incidence of septic episodes and hospital length of stay in severely burned children. J Burn Care Res. 2006 Nov-Dec;27(6):813-8. doi: 10.1097/01.BCR.0000245421.54312.36.

Munster AM, Hoagland HC, Pruitt BA Jr. The effect of thermal injury on serum immunoglobulins. Ann Surg. 1970 Dec;172(6):965-9. doi: 10.1097/00000658-197012000-00006. No abstract available.