Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT05134792
Status:
COMPLETED
Last Update Posted:
2022-11-15
First Post:
2021-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Effect of Pre-emptive Intravenous Immunoglobulin Administration on the Incidence of Septic Episodes in Pediatric Burn Patients: A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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,
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: