Unsupervised Machine Learning for Clustering of Septic Patients to Determine Optimal Treatment

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03752489

Enrollment

51645

Registered

2018-11-26

Start date

2022-04-01

Completion date

2024-03-31

Last updated

2021-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis, Septic Shock, Severe Sepsis

Keywords

Dascena, machine learning, fluid administration, clustering algorithm, mortality, diagnostic

Brief summary

The focus of this study will be to conduct a prospective, randomized controlled trial (RCT) at Cape Regional Medical Center (CRMC), Oroville Hospital (OH), and UCSF Medical Center (UCSF) in which a fluid treatment-specific algorithm will be applied to EHR data for the detection of severe sepsis. For patients determined to have a high risk of severe sepsis, the algorithm will generate automated voice, telephone notification to nursing staff at CRMC, OH, and UCSF. The algorithm's performance will be measured by analysis of the primary endpoint, reductions in in-hospital mortality.

Interventions

DIAGNOSTIC_TESTTreatment-specific InSight

The InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis, and in this study will be customized to differentiate between clusters of patients who respond similarly to fluids treatment according to the nature of their disease progression.

DIAGNOSTIC_TESTInSight

The non-customized InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* All adults above age 18 who are a member of one of the clinical subpopulations studied in this trial are eligible to participate in the study.

Exclusion criteria

* Under age 18

Design outcomes

Primary

Measure	Time frame	Description
In-hospital SIRS-based mortality	Through study completion, an average of 8 months	Mortality attributed to patients meeting two or more SIRS criteria at some point during their stay

Contacts

Primary ContactQingqing Mao, PhD

qmao@dascena.com5108269508

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026