Predictive algoRithm for EValuation and Intervention in SEpsis

NCT ID: NCT03235193

Last Updated: 2021-09-21

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2017-08-30

Brief Summary

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In this prospective study, the ability of a machine learning algorithm to predict sepsis and influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).

Detailed Description

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Conditions

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Sepsis Septic Shock Severe Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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With InSight

Healthcare provider receives an alert from InSight for patients trending towards severe sepsis. Healthcare provider also receives information from the severe sepsis detector in the CHH electronic health record.

Group Type EXPERIMENTAL

Severe Sepsis Detection

Intervention Type OTHER

Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.

Severe Sepsis Prediction

Intervention Type OTHER

Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.

Without Insight

Healthcare provider does not receive any alerts from InSight. Healthcare provider receives information from the severe sepsis detector in the CHH electronic health record.

Group Type ACTIVE_COMPARATOR

Severe Sepsis Detection

Intervention Type OTHER

Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.

Interventions

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Severe Sepsis Detection

Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.

Intervention Type OTHER

Severe Sepsis Prediction

Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adult patients visiting the emergency department, or admitted to the participating intensive care unit (ICU) wards of Cabell Huntington Hospital will be eligible.

Exclusion Criteria

* All patients younger than 18 years of age will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cabell Huntington Hospital

OTHER

Sponsor Role collaborator

Dascena

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hoyt Burdick

Role: PRINCIPAL_INVESTIGATOR

Cabell Huntington Hospital

Locations

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Cabell Huntington Hospital

Huntington, West Virginia, United States

Site Status

Countries

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United States

References

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Calvert J, Desautels T, Chettipally U, Barton C, Hoffman J, Jay M, Mao Q, Mohamadlou H, Das R. High-performance detection and early prediction of septic shock for alcohol-use disorder patients. Ann Med Surg (Lond). 2016 May 10;8:50-5. doi: 10.1016/j.amsu.2016.04.023. eCollection 2016 Jun.

Reference Type BACKGROUND
PMID: 27489621 (View on PubMed)

Calvert JS, Price DA, Chettipally UK, Barton CW, Feldman MD, Hoffman JL, Jay M, Das R. A computational approach to early sepsis detection. Comput Biol Med. 2016 Jul 1;74:69-73. doi: 10.1016/j.compbiomed.2016.05.003. Epub 2016 May 12.

Reference Type BACKGROUND
PMID: 27208704 (View on PubMed)

Desautels T, Calvert J, Hoffman J, Jay M, Kerem Y, Shieh L, Shimabukuro D, Chettipally U, Feldman MD, Barton C, Wales DJ, Das R. Prediction of Sepsis in the Intensive Care Unit With Minimal Electronic Health Record Data: A Machine Learning Approach. JMIR Med Inform. 2016 Sep 30;4(3):e28. doi: 10.2196/medinform.5909.

Reference Type BACKGROUND
PMID: 27694098 (View on PubMed)

Other Identifiers

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1097090-1

Identifier Type: -

Identifier Source: org_study_id

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