NCT05095220

Brief Summary

The study aims to evaluate the performance of NAVOY® Sepsis in predicting the sepsis risk in adult ICU patients. Data collection is performed via automatic retrieval from the electronic health record system to AlgoDx proprietary cloud service where it is analysed in a simulated environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

May 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2023

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

September 30, 2021

Last Update Submit

May 19, 2023

Conditions

Sepsis

Keywords

sepsisICUpredictiondecision supportmachine learningintensive care

Outcome Measures

Primary Outcomes (1)

  • NAVOY® Sepsis prediction performance

    NAVOY® Sepsis prediction output within the simulated environment will be monitored and compared to the observed fulfilment of Sepsis-3 diagnosis criteria and sepsis specific management.

    6 months

Secondary Outcomes (4)

  • Integration validation

    6 months

  • NAVOY® Sepsis prediction results

    6 months

  • Fulfilment of Sepsis-3 criteria

    6 months

  • Sepsis specific management

    6 months

Study Arms (1)

Observational Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ICU patients admitted to the ICU during the enrolment period.

You may qualify if:

  • The subject is admitted to the ICU during the enrolment period.
  • The subject is 18 years of age or older at the time of admission to the ICU.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern General Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Martin Arlbrandt, MD

    Southern General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 27, 2021

Study Start

May 27, 2022

Primary Completion

March 8, 2023

Study Completion

March 8, 2023

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)