Modulation of Molecular Fingerprinting in Pediatric Sepsis

Conditions

• Systemic Inflammatory Response Syndrome

Eligibility Criteria

Sex

ALL

Age

1 Year - 18 Years

Healthy Volunteers

Not accepted

Interventions

• miRNA in Sepsis — PROCEDURE
  miRNA in Sepsis

Study Details

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.

Key Dates

Start date

Mar 31, 2014

Status verified

Oct 2025

Primary completion

Jun 30, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: 10 Patients with sepsis or septic shock
  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.
• Arm: 50 Healthy Patients
  Healthy non-immunocompromised patients between 1-18 years old

Primary Outcome Measure

Risk of Mortality [ Time Frame: Duration of hospital stay, an expected average of 3 weeks ]

Central Contacts

• Frederick A Willyerd, MD
  6029331784
  [email protected]
• Althaia Calla G Ignacio, BSN, MD
  6029333795
  [email protected]

Locations (2)

Find similar trials in Phoenix, AZ

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