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

November 13, 2022 updated by: Hanan Mostafa ,MD, Cairo University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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,

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • LIV GAMMA "S/D treated Human Immunoglobulin "2.5 grams/50 ml

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Through out study completion, average 30 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Through out study completion, average 30 days.
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.
Throughout the study completion average 30 days.
Length of stay
Time Frame: Through out study completion, average 30 day.
days
Through out study completion, average 30 day.
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.
Through out study completion, average 30 days
Mortality rate
Time Frame: 30 days
Number of patients
30 days
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
From date of randomization until the date of first documented progression or date of death from any cause,

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
serum Procalcitonin
Time Frame: Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .
ng/mL
Day 1 ,Day3 ,and on each incidence of sepsis, and through out study completion, average 30 days .
serum IgG
Time Frame: Day 1 and Day 7.
g/L.
Day 1 and Day 7.
serum C-reactive protein
Time Frame: Day 1 , and on each incidence of sepsis, assessed up to 30 days.
mg/L.
Day 1 , and on each incidence of sepsis, assessed up to 30 days.
Serum Malondialdehyde level (MDA)
Time Frame: Day 1 and Day 3
nmol./ml
Day 1 and Day 3
Serum Glutathione peroxidase level
Time Frame: Day 1 and Day 3
U/L
Day 1 and Day 3
Serum Micro RNA 25
Time Frame: Day 1 and Day 3
Fold change
Day 1 and Day 3
Serum lactate
Time Frame: daily,through out study completion, average 30 days
mmol/L
daily,through out study completion, average 30 days
Demographic data as Age
Time Frame: Baseline
In years.
Baseline
Demographic data as Sex
Time Frame: Baseline
sex of the study candidate.
Baseline
Demographic data as total body surface area
Time Frame: Baseline
Total body surface area
Baseline
Depth of burn injured area
Time Frame: Baseline
Rule of nine .,percentage of burn .
Baseline
Hemodynamic data as heart rate
Time Frame: Through out study completion, average 30 days
Heart rate in beats per minute
Through out study completion, average 30 days
Hemodynamic data as oxygen saturation
Time Frame: Through out study completion, average 30 days
oxygen saturation in percent
Through out study completion, average 30 days
Hemodynamic data as body temperature.
Time Frame: Through out study completion, average 30 days
body temperature in degrees Celsius
Through out study completion, average 30 days
Hemodynamic data as Capillary refill time
Time Frame: Daily,through out study completion, average 30 days
seconds
Daily,through out study completion, average 30 days
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.
Through out study completion, average 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hanan Mostafa, lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pt 2221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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