SepsisNCT05311046
Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool
An observational study of Sepsis, run by Computer Technology Associates, Inc. at 1 site in United States.
Trial summary
The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's electronic health record (EHR) system to monitor and assess real-time emergency department… Read more about this study
- Who is it for?
- Ages 3 months to 45 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Pediatric sepsis screening tool (either algorithmic or manual)
- How many people
- 12,961 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Those pediatric patients presenting to the emergency department with a fever and/or concern for infection and screen positive for pediatric sepsis based on existing institutional screening protocol.
Who may be able to join
- Patients 3 months -45 years of age, inclusive
- 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.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with parents or LARs that don't speak English or Spanish
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool Towards Early Recognition and Personalized Therapeutics
The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's electronic health record (EHR) system to monitor and assess real-time emergency department (ED) electronic health record (EHR) data towards the enhancement of early pediatric sepsis recognition and the initiation of timely, aggressive personalized sepsis therapy known to improve patient outcomes.
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.
Read the detailed description
Background and Rationale Existing automated pediatric sepsis screening tools (PSCT) based on consensus criteria currently used in emergency departments do not improve early recognition and/or inform personalized therapeutic decisions leading to improved outcomes. The Improving Pediatric Sepsis Outcomes (IPSO) initiative found that by including patients that receive treatment, the extended criteria captured not only patients who developed sepsis with organ dysfunction (OD), but also those in whom early sepsis was treated with OD potentially averted.
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
- Sepsis
- Being tested
- Pediatric sepsis screening tool (either algorithmic or manual)
- Keywords
- pediatric sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric sepsis screening tool (either algorithmic or manual)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Pediatric sepsis screening tool (either algorithmic or manual) | |
| 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. Receives: Diagnostic Test: Pediatric sepsis screening tool (either algorithmic or manual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Expert System-based Pediatric Sepsis Screening Tool (PSCT)
Over a usability test period, by emulation of the logic of experts in a screening tool that cam be continuously improved with experience, achieve a high level of ED workflow usability towards improved early recognition of IPSO sepsis, as perceived by practicing ED clinicians engaged in usability testing.
Measured: Final 3 months of study period.
High performance Expert System-based Pediatric Sepsis Screening Tool (PSCT)
To derive a high performing (e.g., sensitivity/specificity > 90%, PPV > 40%) PSCT to identify patients in the ED meeting IPSO sepsis criteria using early encounter data (e.g. upon receipt of biomarker data within 1st 1-3 hours of presentation).
Measured: Using "early data" following presentation to ED, e.g., upon receipt of biomarker data within 1st 3 hours of presentation)
Secondary outcomes (1)
Effective sepsis phenotyping for personalized treatment
To show that combined PERSEVERE biomarker and EHR data as clustering features (e.g. using latent class analysis) enhances the detection of clinically useful prognostic phenotypes.
Measured: Features based on 1st 6 hours following presentation in patients diagnosed with sepsis and treatment protocol initiated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Mar 2022
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 12,961 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Computer Technology Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Rainbow Babies and Children's Hospital, Johns Hopkins University, Johns Hopkins All Children's Hospital, Children's Hospital of The King's Daughters
- Responsible party
- Principal investigator, Ioannis Koutroulis, Children's National Research Institute
- Investigators
- Carmelo "Tom" E Velez, PhD, Study director, CTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311046
- Sponsor's protocol ID
- NIAID 1R41AI167224-01
- Status last verified
- Oct 2026
- First submitted
- 20 Mar 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
PubMed 15636651Eisenberg M, Madden K, Christianson JR, Melendez E, Harper MB. Performance of an Automated Screening Algorithm for Early Detection of Pediatric Severe Sepsis. Pediatr Crit Care Med. 2019 Dec;20(12):e516-e523. doi: 10.1097/PCC.0000000000002101.
PubMed 31567896Eisenberg MA, Freiman E, Capraro A, Madden K, Monuteaux MC, Hudgins J, Harper M. Outcomes of Patients with Sepsis in a Pediatric Emergency Department after Automated Sepsis Screening. J Pediatr. 2021 Aug;235:239-245.e4. doi: 10.1016/j.jpeds.2021.03.053. Epub 2021 Mar 30.
PubMed 33798508Iwashyna TJ, Odden A, Rohde J, Bonham C, Kuhn L, Malani P, Chen L, Flanders S. Identifying patients with severe sepsis using administrative claims: patient-level validation of the angus implementation of the international consensus conference definition of severe sepsis. Med Care. 2014 Jun;52(6):e39-43. doi: 10.1097/MLR.0b013e318268ac86.
PubMed 23001437Mathias B, Mira JC, Larson SD. Pediatric sepsis. Curr Opin Pediatr. 2016 Jun;28(3):380-7. doi: 10.1097/MOP.0000000000000337.
PubMed 26983000Weiss SL, Parker B, Bullock ME, Swartz S, Price C, Wainwright MS, Goodman DM. Defining pediatric sepsis by different criteria: discrepancies in populations and implications for clinical practice. Pediatr Crit Care Med. 2012 Jul;13(4):e219-26. doi: 10.1097/PCC.0b013e31823c98da.
PubMed 22460773Scott HF, Brilli RJ, Paul R, Macias CG, Niedner M, Depinet H, Richardson T, Riggs R, Gruhler H, Larsen GY, Huskins WC, Balamuth F; Improving Pediatric Sepsis Outcomes (IPSO) Collaborative Investigators.. Evaluating Pediatric Sepsis Definitions Designed for Electronic Health Record Extraction and Multicenter Quality Improvement. Crit Care Med. 2020 Oct;48(10):e916-e926. doi: 10.1097/CCM.0000000000004505.
PubMed 32931197Lippi G. Sepsis biomarkers: past, present and future. Clin Chem Lab Med. 2019 Aug 27;57(9):1281-1283. doi: 10.1515/cclm-2018-1347. No abstract available.
PubMed 30710482Marshall JC, Reinhart K; International Sepsis Forum. Biomarkers of sepsis. Crit Care Med. 2009 Jul;37(7):2290-8. doi: 10.1097/CCM.0b013e3181a02afc.
PubMed 19487943Taneja I, Reddy B, Damhorst G, Dave Zhao S, Hassan U, Price Z, Jensen T, Ghonge T, Patel M, Wachspress S, Winter J, Rappleye M, Smith G, Healey R, Ajmal M, Khan M, Patel J, Rawal H, Sarwar R, Soni S, Anwaruddin S, Davis B, Kumar J, White K, Bashir R, Zhu R. Combining Biomarkers with EMR Data to Identify Patients in Different Phases of Sepsis. Sci Rep. 2017 Sep 7;7(1):10800. doi: 10.1038/s41598-017-09766-1.
PubMed 28883645Patel K, McElvania E. Diagnostic Challenges and Laboratory Considerations for Pediatric Sepsis. J Appl Lab Med. 2019 Jan;3(4):587-600. doi: 10.1373/jalm.2017.025908. Epub 2018 Nov 21.
PubMed 31639728Lanziotti VS, Povoa P, Soares M, Silva JR, Barbosa AP, Salluh JI. Use of biomarkers in pediatric sepsis: literature review. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):472-482. doi: 10.5935/0103-507X.20160080.
PubMed 28099644Wong HR, Salisbury S, Xiao Q, Cvijanovich NZ, Hall M, Allen GL, Thomas NJ, Freishtat RJ, Anas N, Meyer K, Checchia PA, Lin R, Shanley TP, Bigham MT, Sen A, Nowak J, Quasney M, Henricksen JW, Chopra A, Banschbach S, Beckman E, Harmon K, Lahni P, Lindsell CJ. The pediatric sepsis biomarker risk model. Crit Care. 2012 Oct 1;16(5):R174. doi: 10.1186/cc11652.
PubMed 23025259Jacobs L, Berrens Z, Stenson EK, Zackoff MW, Danziger LA, Lahni P, Wong HR. The Pediatric Sepsis Biomarker Risk Model (PERSEVERE) Biomarkers Predict Clinical Deterioration and Mortality in Immunocompromised Children Evaluated for Infection. Sci Rep. 2019 Jan 23;9(1):424. doi: 10.1038/s41598-018-36743-z.
PubMed 30675002Gardlund B, Dmitrieva NO, Pieper CF, Finfer S, Marshall JC, Taylor Thompson B. Six subphenotypes in septic shock: Latent class analysis of the PROWESS Shock study. J Crit Care. 2018 Oct;47:70-79. doi: 10.1016/j.jcrc.2018.06.012. Epub 2018 Jun 8.
PubMed 29933169
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker-enhanced Artificial Intelligence Based Pediatric Sepsis Screening Tool Towards Early Recognition and Personalized Therapeutics
- ClinicalTrials.gov ID
- NCT05311046
- Acronym / sponsor ID
- NIAID 1R41AI167224-01
- Conditions
- Sepsis
- Keywords
- pediatric sepsis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 12,961 participants (estimated)
- Lead sponsor
- Computer Technology Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Medical Center, Cincinnati, Rainbow Babies and Children's Hospital, Johns Hopkins University, Johns Hopkins All Children's Hospital, Children's Hospital of The King's Daughters
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this proposed research is the derivation of a biomarker-enhanced artificial intelligence (AI)-based pediatric sepsis screening tool (PSCT) (software) that can be used in combination with the hospital's electronic health record (EHR) system to monitor and assess real-time emergency department (ED) electronic health record (EHR) data towards the enhancement of early pediatric sepsis recognition and the initiation of timely, aggressive personalized sepsis therapy known to improve patient outcomes.
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.
Detailed description
Background and Rationale Existing automated pediatric sepsis screening tools (PSCT) based on consensus criteria currently used in emergency departments do not improve early recognition and/or inform personalized therapeutic decisions leading to improved outcomes. The Improving Pediatric Sepsis Outcomes (IPSO) initiative found that by including patients that receive treatment, the extended criteria captured not only patients who developed sepsis with organ dysfunction (OD), but also those in whom early sepsis was treated with OD potentially averted.
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.).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective EHR-data only group | – | Diagnostic Test: Pediatric sepsis screening tool (either algorithmic or manual)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. |
| Prospective EHR and Biomarker data group | – | Diagnostic Test: Pediatric sepsis screening tool (either algorithmic or manual)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. |
Who may qualify
- Ages
- 3 months to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Those pediatric patients presenting to the emergency department with a fever and/or concern for infection and screen positive for pediatric sepsis based on existing institutional screening protocol.
Key inclusion criteria (3 listed)
- Patients 3 months -45 years of age, inclusive
- 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.
Key exclusion criteria (3 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice
- Patients with parents or LARs that don't speak English or Spanish
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Prospective EHR and Biomarker data group, Retrospective EHR-data only group |
Primary outcome
Effective Expert System-based Pediatric Sepsis Screening Tool (PSCT)
Time frame: Final 3 months of study period.
Over a usability test period, by emulation of the logic of experts in a screening tool that cam be continuously improved with experience, achieve a high level of ED workflow usability towards improved early recognition of IPSO sepsis, as perceived by practicing ED clinicians engaged in usability testing.
High performance Expert System-based Pediatric Sepsis Screening Tool (PSCT)
Time frame: Using "early data" following presentation to ED, e.g., upon receipt of biomarker data within 1st 3 hours of presentation)
To derive a high performing (e.g., sensitivity/specificity > 90%, PPV > 40%) PSCT to identify patients in the ED meeting IPSO sepsis criteria using early encounter data (e.g. upon receipt of biomarker data within 1st 1-3 hours of presentation).
1 secondary outcome
Effective sepsis phenotyping for personalized treatment
Time frame: Features based on 1st 6 hours following presentation in patients diagnosed with sepsis and treatment protocol initiated.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 15636651Goldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
- Background: PubMed 31567896Eisenberg M, Madden K, Christianson JR, Melendez E, Harper MB. Performance of an Automated Screening Algorithm for Early Detection of Pediatric Severe Sepsis. Pediatr Crit Care Med. 2019 Dec;20(12):e516-e523. doi: 10.1097/PCC.0000000000002101.
- Background: PubMed 33798508Eisenberg MA, Freiman E, Capraro A, Madden K, Monuteaux MC, Hudgins J, Harper M. Outcomes of Patients with Sepsis in a Pediatric Emergency Department after Automated Sepsis Screening. J Pediatr. 2021 Aug;235:239-245.e4. doi: 10.1016/j.jpeds.2021.03.053. Epub 2021 Mar 30.
- Background: PubMed 23001437Iwashyna TJ, Odden A, Rohde J, Bonham C, Kuhn L, Malani P, Chen L, Flanders S. Identifying patients with severe sepsis using administrative claims: patient-level validation of the angus implementation of the international consensus conference definition of severe sepsis. Med Care. 2014 Jun;52(6):e39-43. doi: 10.1097/MLR.0b013e318268ac86.
- Background: PubMed 26983000Mathias B, Mira JC, Larson SD. Pediatric sepsis. Curr Opin Pediatr. 2016 Jun;28(3):380-7. doi: 10.1097/MOP.0000000000000337.
- Background: PubMed 22460773Weiss SL, Parker B, Bullock ME, Swartz S, Price C, Wainwright MS, Goodman DM. Defining pediatric sepsis by different criteria: discrepancies in populations and implications for clinical practice. Pediatr Crit Care Med. 2012 Jul;13(4):e219-26. doi: 10.1097/PCC.0b013e31823c98da.
- Background: PubMed 32931197Scott HF, Brilli RJ, Paul R, Macias CG, Niedner M, Depinet H, Richardson T, Riggs R, Gruhler H, Larsen GY, Huskins WC, Balamuth F; Improving Pediatric Sepsis Outcomes (IPSO) Collaborative Investigators.. Evaluating Pediatric Sepsis Definitions Designed for Electronic Health Record Extraction and Multicenter Quality Improvement. Crit Care Med. 2020 Oct;48(10):e916-e926. doi: 10.1097/CCM.0000000000004505.
- Background: PubMed 30710482Lippi G. Sepsis biomarkers: past, present and future. Clin Chem Lab Med. 2019 Aug 27;57(9):1281-1283. doi: 10.1515/cclm-2018-1347. No abstract available.
- Background: PubMed 19487943Marshall JC, Reinhart K; International Sepsis Forum. Biomarkers of sepsis. Crit Care Med. 2009 Jul;37(7):2290-8. doi: 10.1097/CCM.0b013e3181a02afc.
- Background: PubMed 28883645Taneja I, Reddy B, Damhorst G, Dave Zhao S, Hassan U, Price Z, Jensen T, Ghonge T, Patel M, Wachspress S, Winter J, Rappleye M, Smith G, Healey R, Ajmal M, Khan M, Patel J, Rawal H, Sarwar R, Soni S, Anwaruddin S, Davis B, Kumar J, White K, Bashir R, Zhu R. Combining Biomarkers with EMR Data to Identify Patients in Different Phases of Sepsis. Sci Rep. 2017 Sep 7;7(1):10800. doi: 10.1038/s41598-017-09766-1.
- Background: PubMed 31639728Patel K, McElvania E. Diagnostic Challenges and Laboratory Considerations for Pediatric Sepsis. J Appl Lab Med. 2019 Jan;3(4):587-600. doi: 10.1373/jalm.2017.025908. Epub 2018 Nov 21.
- Background: PubMed 28099644Lanziotti VS, Povoa P, Soares M, Silva JR, Barbosa AP, Salluh JI. Use of biomarkers in pediatric sepsis: literature review. Rev Bras Ter Intensiva. 2016 Oct-Dec;28(4):472-482. doi: 10.5935/0103-507X.20160080.
- "Introduction to Classification \& Regression Trees (CART) - Data Science Central."Link provided by the sponsor.
- "Plan-Do-Study-Act (PDSA) Worksheet \| IHI - Institute for Healthcare Improvement."Link provided by the sponsor.
- "OMOP Common Data Model - OHDSI."Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmelo "Tom" E Velez, PhD study director
CTA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Computer Technology Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Expert System-based Pediatric Sepsis Screening Tool (PSCT) (time frame: Final 3 months of study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05311046, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.