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Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.
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.
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 .
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cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intravenous immunoglobulin (IVIG) | No Intervention | The control group are burn patients with inclusion criteria that did not receive IVIG. | |
| Intravenous immunoglobulin (IVIG) group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous immunoglobulin | Drug | 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. |
| 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. |
| 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 |
| 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. |
Inclusion Criteria:
All burn patients 1 to 5 years old with 10% or greater burn area of TBSA .
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanan Mostafa | lecturer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24235922 | Result | 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. | |
| 17091076 | Result | 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. |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
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, |
| 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 |
| 5496482 | Result | 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. |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |