Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
NCT ID: NCT05311046
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
12961 participants
OBSERVATIONAL
2026-04-01
2029-03-31
Brief Summary
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It is hypothesized that the screening performance (e.g., positive predictive value) of the envisioned screening tool will be significantly enhanced by the inclusion of a biomarker panel test results (PERSEVERE) that have been shown to be effective in prediction of clinical deterioration in non-critically ill immunocompromised pediatric patients evaluated for infection. It is also hypothesized that enhanced phenotypes can be derived by clustering PERSEVERE biomarkers combined with routinely collected EHR data towards improved personalized medicine.
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Detailed Description
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The objective of the proposed effort is to derive and retrospectively validate a biomarker-enhanced AI-based pediatric sepsis screening tool that can be used to screen ED EHR data to improve early recognition, severity stratification, and the timely initiation of personalized sepsis therapy. CTA and its 6 institutional partners jointly propose to establish two de-identified patient registries: 1) the "EHR-data only cohort" (N = 2000) and 2) the "EHR + biomarker data cohort" (N = 400) in support of this objective.
Encounter data elements to be abstracted from EHRs for inclusion in these registries include both structured (e.g., time-stamped physiological measurements, treatments, procedures, outcomes) as well as free text notes.
Data Analysis and biases All study data, including physiological data extracted from patient EHR and results of biomarker assays will be analyzed using a variety of machine learning algorithms and techniques towards producing a high precision sepsis screening predictive model. Analytic methods involve standard descriptive statistical analysis of predictive classification performance (e.g., AUC, sensitivity/specificity, PPV, etc.).
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Retrospective EHR-data only group
Members of this group are pediatric patients between the ages of 3 months to 45 years inclusive, that presented to one of the six participating institution's emergency department between the years 2016-2021 and screened positive for suspicion of sepsis using the institution's existing pediatric sepsis screening protocol and receive a blood culture order. Current pediatric screening/alerting tools are known to be highly sensitive but poorly specific. "Cases" in this cohort will be comprised of those that are ultimately diagnosed with sepsis and/or receive protocolized sepsis treatment. "Controls" in this cohort will be those with a false positive alert, i.e., are not diagnosed with sepsis and do not receive protocolized sepsis treatment.
Pediatric sepsis screening tool (either algorithmic or manual)
All participating institutions employ either an algorithmic, manual, or combined algorithmic/manual pediatric sepsis screening protocol for patients that present with fever and/or a concern for infection. While the specific parameters tested in screening tools differ, they generally consist of tests for a systemic inflammatory response (e.g. SIRS) and/or organ dysfunction (e.g. SOFA) and/or high susceptibility (e.g. immunocompromised) factors.
Prospective EHR and Biomarker data group
Members of this group are pediatric patients between the ages of 3 months to 45 years inclusive, that presented to one of the six participating institution's emergency department during the study enrollment period, screen positive for suspicion of sepsis using the institution's existing pediatric sepsis screening protocol, receive a blood culture order and provide informed consent/assent for the collection of a 1-5 mL blood sample to be used to measure PERSEVERE biomarkers. Members of this cohort will have also consented to the reuse of their medical record data for the research. Current pediatric screening/alerting tools are known to be highly sensitive but poorly specific. "Cases" in this cohort will be comprised of those that are ultimately diagnosed with sepsis and/or receive protocolized sepsis treatment. "Controls" in this cohort will be those with a false positive alert, i.e., are not diagnosed with sepsis and do not receive protocolized sepsis treatment.
Pediatric sepsis screening tool (either algorithmic or manual)
All participating institutions employ either an algorithmic, manual, or combined algorithmic/manual pediatric sepsis screening protocol for patients that present with fever and/or a concern for infection. While the specific parameters tested in screening tools differ, they generally consist of tests for a systemic inflammatory response (e.g. SIRS) and/or organ dysfunction (e.g. SOFA) and/or high susceptibility (e.g. immunocompromised) factors.
Interventions
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Pediatric sepsis screening tool (either algorithmic or manual)
All participating institutions employ either an algorithmic, manual, or combined algorithmic/manual pediatric sepsis screening protocol for patients that present with fever and/or a concern for infection. While the specific parameters tested in screening tools differ, they generally consist of tests for a systemic inflammatory response (e.g. SIRS) and/or organ dysfunction (e.g. SOFA) and/or high susceptibility (e.g. immunocompromised) factors.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with sepsis by a clinician or trigger a sepsis alert and a blood culture is ordered. Controls will be false positive patients.
* For those patients that will be prospectively enrolled for blood sample collection: will require a venipuncture or intravenous line placement.
Exclusion Criteria
* Patients with parents or LARs that don't speak English or Spanish
* Pregnancy
3 Months
45 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Rainbow Babies and Children's Hospital
OTHER
Johns Hopkins University
OTHER
George Washington University
OTHER
All Children's Research Institute
UNKNOWN
Computer Technology Associates, Inc.
INDUSTRY
Responsible Party
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Ioannis Koutroulis
Assistant Professor of Pediatrics, Emergency Medicine, Genomics and Precision Medicine
Principal Investigators
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Carmelo "Tom" E Velez, PhD
Role: STUDY_DIRECTOR
CTA
Locations
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Children's National Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Ioannis Koutroulis
Role: primary
References
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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"Introduction to Classification \& Regression Trees (CART) - Data Science Central."
"Plan-Do-Study-Act (PDSA) Worksheet \| IHI - Institute for Healthcare Improvement."
"OMOP Common Data Model - OHDSI."
Other Identifiers
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NIAID 1R41AI167224-01
Identifier Type: -
Identifier Source: org_study_id
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