Modulation of Molecular Fingerprinting in Pediatric Sepsis

Not Applicable

• Conditions: Systemic Inflammatory Response Syndrome
• Interventions: Procedure: miRNA in Sepsis

• Registration Number: NCT02055105
• Lead Sponsor: Phoenix Children's Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-01-27
• Study First Submitted QC: 2014-02-03
• Study First Posted: 2014-02-04
• Study Start: 2014-03
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Last Update Submitted: 2015-06-29
• Last Update Posted: 2015-06-30
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
miRNA	miRNA in Sepsis	-

Primary Outcome Measures

Name	Time	Method
Risk of Mortality	Duration of hospital stay, an expected average of 3 weeks	Will compare PRISM 3 scores from baseline to hospital discharge.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States