Clinical Validation of NAVOY® Acute Kidney Injury in Swedish ICU Patients

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT05424874
• Lead Sponsor: AlgoDx

Brief Summary

The study aims to evaluate the performance of the prediction algorithm NAVOY® AKI in a Swedish adult ICU patient population versus fulfilment of KDIGO diagnostic criteria.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-02
• Primary Completion: 2021-11-01
• Study Completion: 2021-11-01
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-12
• Last Update Posted: 2022-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

Inclusion Criteria

• The study will only include the subjects from the SEP-SE-02 study population. (NCT04570618)

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction performance of NAVOY® AKI	Data from ICU stay between December 2020 to October 2021.	The sensitivity, specificity, and accuracy will be calculated comparing the algorithm's predictions with the true AKI outcome.

Trial Locations

Locations (1)

Intensiv- och perioperativ vård; 🇸🇪 Malmö, Sweden