Early Prediction of Sepsis

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Device: Unblinded AlgoDx Sepsis Prediction Algorithm; Other: Blinded AlgoDx Sepsis Prediction Algorithm

• Registration Number: NCT04570618
• Lead Sponsor: AlgoDx

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-22
• Study First Submitted QC: 2020-09-25
• Study First Posted: 2020-09-30
• Study Start: 2020-12-01
• Status Verified: 2021-11
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Last Update Submitted: 2021-11-02
• Last Update Posted: 2021-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care + AlgoDx Sepsis Prediction Algorithm	Unblinded AlgoDx Sepsis Prediction Algorithm	Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines, and sepsis prediction algorithm alerts are unblinded to clinical staff.
Standard of Care	Blinded AlgoDx Sepsis Prediction Algorithm	Subjects are monitored for potential development of sepsis according to the local established clinical management guidelines.

Primary Outcome Measures

Name	Time	Method
Validate the prognostic accuracy of the algorithm at predicting sepsis.	Up to 30 days (ICU hospitalization period)	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).

Trial Locations

Locations (1)

Intensiv- och perioperativ vård; 🇸🇪 Malmö, Sweden