Early Prediction of Sepsis

Sepsis Clinical Trial

— ExPRESS  

Official title:

Early Prediction of Sepsis in Hospitalized Patients Using a Machine Learning Algorithm, a Randomized Clinical Validation Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04570618
• Other study ID #: SEP-SE-02
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: AlgoDx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this clinical trial a novel Medical Device Software will be validated prospectively. The software incorporates a machine learning algorithm capable of predicting sepsis by using routine clinical variables in adult patients at Intensive Care Units.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult patient (age =18 years).

2. Patient is admitted to the ICU during the recruitment period of the trial.

Exclusion Criteria:

1. Patient is participating in another interventional clinical trial which, as judged by the investigator, could potentially impact variables used by the sepsis prediction algorithm or has participated in such interventional clinical trial within the last 30 days.

2. Patient is known to be pregnant.

3. Death is deemed imminent and inevitable, at the investigator's discretion.

4. Patient has, due to chronic reduced mental capacity, been assessed by the investigator as incapable of making an informed decision

5. Patient has previously been enrolled in this trial.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Device:
• Unblinded AlgoDx Sepsis Prediction Algorithm
When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software.

Other:
• Blinded AlgoDx Sepsis Prediction Algorithm
Standard of Care, i.e. no sepsis prediction alert.

Locations

Country	Name	City	State
Sweden	Intensiv- och perioperativ vård	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
AlgoDx

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate the prognostic accuracy of the algorithm at predicting sepsis.	In order to clinically validate the sepsis prediction performance the following endpoints have been selected: accuracy,; specificity, and; sensitivity of the AlgoDx Sepsis Prediction Algorithm in the SoC group (not possible to assess these in the SoC + Algorithm cohort).	Up to 30 days (ICU hospitalization period)