Clinical trial NCT02055105: Modulation of Molecular Fingerprinting in Pediatric Sepsis
Official title: Modulation of Molecular Fingerprinting in Pediatric Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome
Keywords: Pediatric Sepsis
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2014-02-04
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Risk of Mortality
timeFrame: Duration of hospital stay, an expected average of 3 weeks
Secondary outcomes:
measure: Organ Failure
timeFrame: Duration of hospital stay, an expected average of 3 weeks
measure: Organ Dysfunction
timeFrame: Duration of hospital stay, an expected average of 3 weeks
measure: Patient acuity
timeFrame: Duration of hospital stay, an expected average of 3 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
Study officials:
affiliation: Phoenix Children's Hospital
name: Frederick A Willyerd, MD
role: PRINCIPAL_INVESTIGATOR
References: