NCT05134792

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 1 Year – 5 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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,

Conditions

• Burn Shock

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2021-10-10
• Primary completion: 2022-07-16
• Completion: 2022-07-16
• First posted: 2021-11-26
• Last updated: 2022-11-15

Locations

1 site across 1 country: Egypt