Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients
Study Details
Study Description
Brief Summary
Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
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.
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On each septic or septic shock episode in either groups, the patients will be treated with appropriate antibiotics empirically or culture-based.
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Assessments
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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.
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Parameters to be measured
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Serum immunoglobulin G( IgG) level,
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Serum micro RNA (miR-25) ,
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Serum C reactive protein (CRP) level,
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Serum lactate,
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Serum Procalcitonin
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Serum Malondialdehyde(MDA).
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Serum Glutathione Peroxidase .
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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 Design
Arms and Interventions
| 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:
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Outcome Measures
Primary Outcome Measures
- Incidence of sepsis during ICU stay will be recorded. [Through out study completion, average 30 days.]
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.
Secondary Outcome Measures
- Incidence of septic shock [Through out study completion, average 30 days.]
Defined by evidence of sepsis as previously mentioned and need for inotropes to support circulation.
- Number of septic episodes [Throughout the study completion average 30 days.]
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.
- Length of stay [Through out study completion, average 30 day.]
days
- PEdiatric Logistic Organ Dysfunction score 2 (PELOD-2) [Through out study completion, average 30 days]
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.
- Mortality rate [30 days]
Number of patients
- Days of mechanical ventilation [From date of randomization until the date of first documented progression or date of death from any cause,]
days
Other Outcome Measures
- serum Procalcitonin [Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .]
ng/mL
- serum IgG [Day 1 and Day 7.]
g/L.
- serum C-reactive protein [Day 1 , and on each incidence of sepsis, assessed up to 30 days.]
mg/L.
- Serum Malondialdehyde level (MDA) [Day 1 and Day 3]
nmol./ml
- Serum Glutathione peroxidase level [Day 1 and Day 3]
U/L
- Serum Micro RNA 25 [Day 1 and Day 3]
Fold change
- Serum lactate [daily,through out study completion, average 30 days]
mmol/L
- Demographic data as Age [Baseline]
In years.
- Demographic data as Sex [Baseline]
sex of the study candidate.
- Demographic data as total body surface area [Baseline]
Total body surface area
- Depth of burn injured area [Baseline]
Rule of nine .,percentage of burn .
- Hemodynamic data as heart rate [Through out study completion, average 30 days]
Heart rate in beats per minute
- Hemodynamic data as oxygen saturation [Through out study completion, average 30 days]
oxygen saturation in percent
- Hemodynamic data as body temperature. [Through out study completion, average 30 days]
body temperature in degrees Celsius
- Hemodynamic data as Capillary refill time [Daily,through out study completion, average 30 days]
seconds
- Hemodynamic data as systolic ,diastolic and mean non invasive blood pressure. [Through out study completion, average 30 days]
Systolic ,Diastolic and mean non invasive blood pressure in mmHg.
Eligibility Criteria
Criteria
Inclusion Criteria:
All burn patients 1 to 5 years old with 10% or greater burn area of TBSA .
Exclusion Criteria:
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Patients with septic shock (evidence of infection and inotropes) .
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Burns more than 48 hours duration.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cairo University | Cairo | Egypt |
Sponsors and Collaborators
- Cairo University
Investigators
- Principal Investigator: Hanan Mostafa, lecturer
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pt 2221