Modulation of Molecular Fingerprinting in Pediatric Sepsis

Phoenix Children's Hospital

Status: Enrolling

Conditions: Systemic Inflammatory Response Syndrome

Treatments: Procedure: miRNA in Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT02055105

PHNX-biosep-12159

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 2 patient groups

10 Patients with sepsis or septic shock

Description:

Previously healthy, non-immunocompromised patients, between the ages of 1 and 18, who are being admitted to the PCH PICU for sepsis or septic shock, will be enrolled. Blood samples, urine samples and buccal swabs will be obtained from these patients 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 PRISM scores and 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.

Treatment:

Procedure: miRNA in Sepsis

50 Healthy Patients

Description:

Healthy non-immunocompromised patients between 1-18 years old