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.

Study Overview

• Status: Completed
• Conditions: Burn Shock
• Intervention / Treatment: Drug: intravenous immunoglobulin

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cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intravenous immunoglobulin (IVIG); The control group are burn patients with inclusion criteria that did not receive IVIG.
Experimental: Intravenous immunoglobulin (IVIG) group; 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.	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.; Other Names: LIV GAMMA "S/D treated Human Immunoglobulin "2.5 grams/50 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Through out study completion, average 30 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of septic shock	Defined by evidence of sepsis as previously mentioned and need for inotropes to support circulation.	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.	Throughout the study completion average 30 days.
Length of stay	days	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.	Through out study completion, average 30 days
Mortality rate	Number of patients	30 days
Days of mechanical ventilation	days	From date of randomization until the date of first documented progression or date of death from any cause,

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum Procalcitonin	ng/mL	Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .
serum IgG	g/L.	Day 1 and Day 7.
serum C-reactive protein	mg/L.	Day 1 , and on each incidence of sepsis, assessed up to 30 days.
Serum Malondialdehyde level (MDA)	nmol./ml	Day 1 and Day 3
Serum Glutathione peroxidase level	U/L	Day 1 and Day 3
Serum Micro RNA 25	Fold change	Day 1 and Day 3
Serum lactate	mmol/L	daily,through out study completion, average 30 days
Demographic data as Age	In years.	Baseline
Demographic data as Sex	sex of the study candidate.	Baseline
Demographic data as total body surface area	Total body surface area	Baseline
Depth of burn injured area	Rule of nine .,percentage of burn .	Baseline
Hemodynamic data as heart rate	Heart rate in beats per minute	Through out study completion, average 30 days
Hemodynamic data as oxygen saturation	oxygen saturation in percent	Through out study completion, average 30 days
Hemodynamic data as body temperature.	body temperature in degrees Celsius	Through out study completion, average 30 days
Hemodynamic data as Capillary refill time	seconds	Daily,through out study completion, average 30 days
Hemodynamic data as systolic ,diastolic and mean non invasive blood pressure.	Systolic ,Diastolic and mean non invasive blood pressure in mmHg.	Through out study completion, average 30 days

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Hanan Mostafa, lecturer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Actual): July 16, 2022
• Study Completion (Actual): July 16, 2022

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
• Other Study ID Numbers: Pt 2221

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No