Gene Expression Objective Definition of Early Sepsis In Children (GEODESIC)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital
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Seattle, Washington, United States, 98105
- Seattle Children's Hospital, Harborview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
INSI Cohort
- Admitted to the PICU
- New severe trauma OR
- New thermal burns OR
- Rheumatologic diagnoses OR
- Post-initiation (or circuit change) of extracorporeal life support OR
- Post anoxic-ischemic-reperfusion insults OR
- Infants undergoing cardiac surgery with cardiopulmonary bypass OR
- CAR-T cell therapy
- Parents speak English or Spanish AND
- Not previously enrolled in the GEODESIC investigation
Pediatric Bacterial Sepsis Cohort
- Admitted to the PICU
- Parents speak English or Spanish AND
- Exhibit SIRS criteria including at least fever/hypothermia or leukocytosis/leukopenia or left shift on the leukocyte differential AND
- Strongly suspected or documented source of bacterial infection per primary care team
- Not previously enrolled in the GEODESIC investigation
Pediatric Bacterial Sepsis Cohort
- Admitted to the PICU
- Parents speak English or Spanish AND
- Positive PCR or culture verifying a viral infection
- Not previously enrolled in the GEODESIC investigation
Exclusion Criteria:
- Not expected to survive the PICU stay
- Child has 'ward of the state' status
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Suspected/documented bacterial sepsis
Patients have evidence of an acute bacterial infection with organ dysfunction
|
mRNA expression scores
|
|
Suspected/documented viral sepsis
Patients have evidence of an acute viral infection with organ dysfunction
|
mRNA expression scores
|
|
Infection negative systemic inflammation (SIRS)
Patients have no active infection but exhibit SIRS
|
mRNA expression scores
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mRNA expression
Time Frame: At PICU admission and 48 hours later
|
SeptiCyte (various) gene expression scores
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At PICU admission and 48 hours later
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jerry J Zimmerman, MD, PhD, Seattle Children's Research Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001733
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