Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients
Condition: Burn Shock
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

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,
    

Intervention name(s): intravenous immunoglobulin
Intervention type(s): Drug
Intervention description(s): 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.
Other intervention name(s): LIV GAMMA "S/D treated Human Immunoglobulin "2.5 grams/50 ml
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention