Modulation of Molecular Fingerprinting in Pediatric Sepsis

Study Overview
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Brief Summary
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The goal of this study is to demonstrate the sensitivity and specificity of detecting circulating micro RNA (miRNA) biomarkers in pediatric septic patients. It will also follow expression and modulation of levels in response to therapy in comparison to current biomarkers.

Detailed Description
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This study will aid in the evaluation of determining the accuracy of these miRNAs in pediatric patients and help in establishing pilot data for additional studies in the future. The testing will include blood samples, urine samples and buccal swabs from patients who meet eligibility at 5 time points to analyze biomarkers. Study participants will receive standard of care with antimicrobials and any additional appropriate cardiovascular or respiratory support per the clinical team. The samples will collected and stored at -80 until analysis can be performed. In addition to, during the course of the hospitalization, the enrolled patient will have data collected to calculate severity scores, including updated Pediatric Risk of Mortality (PRISM III) scores and simplified Therapeutic Intervention Scoring System(TISS-28) scores. All patient information will be de-identified. A standard procedure manual will be developed detailing the methods for data collection and entry. Data will be recorded in a de-identified manner on a Microsoft Excel database on a secure institutional server by the institutional staff. Data will then be analyzed to determine correlation of biomarkers to morbidity and mortality for these patients.

Official Title
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Modulation of Molecular Fingerprinting in Pediatric Sepsis

Conditions
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Systemic Inflammatory Response Syndrome

Intervention / Treatment
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* Procedure: miRNA in Sepsis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1 through 18 years Patients admitted to the PICU with concerns for sepsis or those developing sepsis during their admission to the hospital. Patients must be enrolled int he study from arrival time tot he ED up to 24 hours from the time of initiation of antibiotic therapy for treatment of sepsis or septic shock. Signed informed consent. Exclusion Criteria: Patients <1 year of age and greater than 18 years of age.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: miRNA<br> | Procedure: miRNA in Sepsis<br>* miRNA in Sepsis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of Mortality | Will compare PRISM 3 scores from baseline to hospital discharge. | Duration of hospital stay, an expected average of 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ Failure | Will compare sequential organ failure assessment (SOFA) scores throughout hospitalization. | Duration of hospital stay, an expected average of 3 weeks | 
| Organ Dysfunction | Will compare pediatric multiple organ dysfunction scores (PMODS) throughout hospitalization | Duration of hospital stay, an expected average of 3 weeks | 
| Patient acuity | Will assess TISS-28 scores throughout hospitalization. | Duration of hospital stay, an expected average of 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric Sepsis