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

Burn Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05134792
• Other study ID #: Pt 2221
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 10, 2021
• Est. completion date: July 16, 2022

Study information

• Verified date: November 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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,

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 16, 2022
• Est. primary completion date: July 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burn Shock
• Burns

Intervention

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.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. — View Citation

Munster AM, Hoagland HC, Pruitt BA Jr. The effect of thermal injury on serum immunoglobulins. Ann Surg. 1970 Dec;172(6):965-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	serum Procalcitonin	ng/mL	Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .
Other	serum IgG	g/L.	Day 1 and Day 7.
Other	serum C-reactive protein	mg/L.	Day 1 , and on each incidence of sepsis, assessed up to 30 days.
Other	Serum Malondialdehyde level (MDA)	nmol./ml	Day 1 and Day 3
Other	Serum Glutathione peroxidase level	U/L	Day 1 and Day 3
Other	Serum Micro RNA 25	Fold change	Day 1 and Day 3
Other	Serum lactate	mmol/L	daily,through out study completion, average 30 days
Other	Demographic data as Age	In years.	Baseline
Other	Demographic data as Sex	sex of the study candidate.	Baseline
Other	Demographic data as total body surface area	Total body surface area	Baseline
Other	Depth of burn injured area	Rule of nine .,percentage of burn .	Baseline
Other	Hemodynamic data as heart rate	Heart rate in beats per minute	Through out study completion, average 30 days
Other	Hemodynamic data as oxygen saturation	oxygen saturation in percent	Through out study completion, average 30 days
Other	Hemodynamic data as body temperature.	body temperature in degrees Celsius	Through out study completion, average 30 days
Other	Hemodynamic data as Capillary refill time	seconds	Daily,through out study completion, average 30 days
Other	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
Primary	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	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.
Secondary	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.
Secondary	Length of stay	days	Through out study completion, average 30 day.
Secondary	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
Secondary	Mortality rate	Number of patients	30 days
Secondary	Days of mechanical ventilation	days	From date of randomization until the date of first documented progression or date of death from any cause,