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NCT Number: NCT05134792

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.

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Key information

Conditions

Burn Shock

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Cairo University

Cairo, Egypt

About this 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.
  • 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,

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: LIV GAMMA "S/D treated Human Immunoglobulin "2.5 grams/50 ml

Primary outcomes

  1. Incidence of sepsis during ICU stay will be recorded.

    Time frame: 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 outcomes

  1. Incidence of septic shock

    Time frame: Through out study completion, average 30 days.

    Defined by evidence of sepsis as previously mentioned and need for inotropes to support circulation.

  2. Number of septic episodes

    Time frame: 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.

  3. Length of stay

    Time frame: Through out study completion, average 30 day.

    days

  4. PEdiatric Logistic Organ Dysfunction score 2 (PELOD-2)

    Time frame: 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.

  5. Mortality rate

    Time frame: 30 days

    Number of patients

  6. Days of mechanical ventilation

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause,

    days

Other outcomes

  1. serum Procalcitonin

    Time frame: Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .

    ng/mL

  2. serum IgG

    Time frame: Day 1 and Day 7.

    g/L.

  3. serum C-reactive protein

    Time frame: Day 1 , and on each incidence of sepsis, assessed up to 30 days.

    mg/L.

  4. Serum Malondialdehyde level (MDA)

    Time frame: Day 1 and Day 3

    nmol./ml

  5. Serum Glutathione peroxidase level

    Time frame: Day 1 and Day 3

    U/L

  6. Serum Micro RNA 25

    Time frame: Day 1 and Day 3

    Fold change

  7. Serum lactate

    Time frame: daily,through out study completion, average 30 days

    mmol/L

  8. Demographic data as Age

    Time frame: Baseline

    In years.

  9. Demographic data as Sex

    Time frame: Baseline

    sex of the study candidate.

  10. Demographic data as total body surface area

    Time frame: Baseline

    Total body surface area

  11. Depth of burn injured area

    Time frame: Baseline

    Rule of nine .,percentage of burn .

  12. Hemodynamic data as heart rate

    Time frame: Through out study completion, average 30 days

    Heart rate in beats per minute

  13. Hemodynamic data as oxygen saturation

    Time frame: Through out study completion, average 30 days

    oxygen saturation in percent

  14. Hemodynamic data as body temperature.

    Time frame: Through out study completion, average 30 days

    body temperature in degrees Celsius

  15. Hemodynamic data as Capillary refill time

    Time frame: Daily,through out study completion, average 30 days

    seconds

  16. Hemodynamic data as systolic ,diastolic and mean non invasive blood pressure.

    Time frame: Through out study completion, average 30 days

    Systolic ,Diastolic and mean non invasive blood pressure in mmHg.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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