Gene Expression Objective Definition of Early Sepsis In Children
Condition: Sepsis; Non-Infectious Systemic Inflammatory Response Syndrome
MeSH terms: Sepsis; Toxemia; Systemic Inflammatory Response Syndrome
Study type: Observational

Summary: 
      GEODESIC is a prospective descriptive cohort investigation that will examine the
      generalizability of the novel host gene expression biomarkers, SeptiCyteTM LAB, SeptiCyteTM
      VIRUS, SeptiCyteTM BACT, and SeptiCyteTM TRIAGE (collectively 18 genes or SeptiCyteTM LVBT)
      and SeptiCyteTM RAPID, for differentiating children with bacterial sepsis, versus severe
      viral illness, versus non-infectious related systemic inflammatory response syndrome.
    

Detailed description: 
      Specific Aim 1. Validate the robustness of the SeptiCyteTM LVBT gene expression signatures
      for providing clear discrimination between critically ill children with bacterial sepsis
      versus severe viral illness versus infection-negative systemic inflammation (INSI) secondary
      to a variety of etiologies.

      Approach: We will expand our previous Genotypes And Phenotypes in Pediatric SIRS and Sepsis
      (GAPPSS) INSI cohort to children with recent trauma, thermal burns, anoxic-ischemic
      reperfusion events, exposure to cardiopulmonary bypass, extracorporeal life support, or
      dialytic therapy, CAR-T cell therapy, and various rheumatologic diagnoses. e we will recruit
      children with bacterial and viral infection who demonstrate a spectrum of illness severity
      and organ dysfunction. This specific aim will demonstrate the generalizability of SeptiCyteTM
      LVBT among critically children with life-threatening infectious disease or INSI.

      Specific Aim 2. Determine if SeptiCyteTM LVBT gene expression signatures trend towards
      resolution of previously induced or suppressed gene expression states as critical illness
      resolves.

      Approach: We will obtain paired blood samples for SeptiCyteTM LVBT gene expression, the first
      around the time of intensive care unit (ICU) admission (critically ill) and the second at ICU
      discharge approximately 48 hours later (transition to acute care). Resolution of critical
      illness will be quantified by serial daily measures of composite organ dysfunction.

      Specific Aim 3. Ascertain that performance of SeptiCyteTM RAPID utilizing a point of care
      device at Seattle Children's will be equivalent to centralized assessment using SeptiCyteTM
      LAB.

      Approach: Blood samples will be processed on site (Seattle Children's) for SeptiCyte RAPID
      testing. SeptiCyteTM RAPID is the result of the translation of the SeptiCyteTM LAB test to
      the cartridge-based Biocartis Idylla™ platform.
    

Intervention name(s): SeptiCyte (various)
Intervention type(s): Diagnostic Test
Intervention description(s): mRNA expression scores
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill children with systemic inflammatory response secondary to bacterial or viral
        sepsis or non-infectious SIRS
      
Biospecimen description: 
      Paired blood samples for paired mRNA expression analysis, the first around the time of PICU
      admission and the second around 48 hours later