Predictive algoRithm for EValuation and Intervention in SEpsis (PREVISE)

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ClinicalTrials.gov Identifier: NCT03235193

Recruitment Status : Unknown

Verified August 2017 by Dascena.
Recruitment status was: Recruiting

First Posted : August 1, 2017

Last Update Posted : August 3, 2017

Sponsor:

Collaborator:

Cabell Huntington Hospital

Information provided by (Responsible Party):

Dascena

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Sepsis Septic Shock Severe Sepsis	Other: Severe Sepsis Prediction Other: Severe Sepsis Detection	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	1241 participants
Allocation:	Non-Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Prediction of Severe Sepsis Using a Machine Learning Algorithm
Actual Study Start Date :	August 1, 2017
Estimated Primary Completion Date :	October 2017
Estimated Study Completion Date :	October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Facilities Sepsis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Other: Severe Sepsis Prediction Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly. Other: 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.
Active Comparator: 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.	Other: 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.

Arm

Intervention/treatment

Experimental: 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.

Other: Severe Sepsis Prediction

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

Other: 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.

Active Comparator: 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.

Other: Severe Sepsis Detection

Outcome Measures

Primary Outcome Measures :

In-hospital mortality [ Time Frame: Through study completion, an average of 30 days ]

Secondary Outcome Measures :

Hospital length of stay [ Time Frame: Through study completion, an average of 30 days ]

Other Outcome Measures:

Hospital readmission [ Time Frame: Through study completion, an average of 30 days ]
ICU length of stay [ Time Frame: Through study completion, an average of 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03235193

Contacts

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Contact: Ritankar Das	8722285332	ritankar@dascena.com

Locations

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United States, West Virginia
Cabell Huntington Hospital	Recruiting
Huntington, West Virginia, United States, 25701
Contact: Hoyt Burdick

Sponsors and Collaborators

Dascena

Cabell Huntington Hospital

Investigators

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Principal Investigator:	Hoyt Burdick	Cabell Huntington Hospital

More Information

Publications:

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.

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.

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.

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Responsible Party:	Dascena
ClinicalTrials.gov Identifier:	NCT03235193
Other Study ID Numbers:	1097090-1
First Posted:	August 1, 2017 Key Record Dates
Last Update Posted:	August 3, 2017
Last Verified:	August 2017

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Sepsis Toxemia Infection	Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes

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