Clinical trial NCT05134792: Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients
Official title: Effect of Pre-emptive Intravenous Immunoglobulin Administration on the Incidence of Septic Episodes in Pediatric Burn Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Burn Shock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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,

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of sepsis during ICU stay will be recorded.
timeFrame: Through out study completion, average 30 days.
Secondary outcomes:
measure: Incidence of septic shock
timeFrame: Through out study completion, average 30 days.
measure: Number of septic episodes
timeFrame: Throughout the study completion average 30 days.
measure: Length of stay
timeFrame: Through out study completion, average 30 day.
measure: PEdiatric Logistic Organ Dysfunction score 2 (PELOD-2)
timeFrame: Through out study completion, average 30 days
measure: Mortality rate
timeFrame: 30 days
measure: Days of mechanical ventilation
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause,
Other outcomes:
measure: serum Procalcitonin
timeFrame: Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .
measure: serum IgG
timeFrame: Day 1 and Day 7.
measure: serum C-reactive protein
timeFrame: Day 1 , and on each incidence of sepsis, assessed up to 30 days.
measure: Serum Malondialdehyde level (MDA)
timeFrame: Day 1 and Day 3
measure: Serum Glutathione peroxidase level
timeFrame: Day 1 and Day 3
measure: Serum Micro RNA 25
timeFrame: Day 1 and Day 3
measure: Serum lactate
timeFrame: daily,through out study completion, average 30 days
measure: Demographic data as Age
timeFrame: Baseline
measure: Demographic data as Sex
timeFrame: Baseline
measure: Demographic data as total body surface area
timeFrame: Baseline
measure: Depth of burn injured area
timeFrame: Baseline
measure: Hemodynamic data as heart rate
timeFrame: Through out study completion, average 30 days
measure: Hemodynamic data as oxygen saturation
timeFrame: Through out study completion, average 30 days
measure: Hemodynamic data as body temperature.
timeFrame: Through out study completion, average 30 days
measure: Hemodynamic data as Capillary refill time
timeFrame: Daily,through out study completion, average 30 days
measure: Hemodynamic data as systolic ,diastolic and mean non invasive blood pressure.
timeFrame: Through out study completion, average 30 days
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: lecturer
name: Hanan Mostafa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.