Modulation of Molecular Fingerprinting in Pediatric Sepsis



Status:Completed
Conditions:Infectious Disease, Hospital
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:1 - 18
Updated:4/2/2016
Start Date:March 2014
End Date:August 2015
Contact:Amit Misra, MD
Email:amisra@phoenixchildrens.com
Phone:6029331784

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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.

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.

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.
We found this trial at
1
site
1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
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