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NCT05424874 Clinical Trial

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

Acute Kidney Injury Clinical Trial

— ExTRACT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05424874
Other study ID # AKI-SE-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2, 2020
Est. completion date November 1, 2021

Study information
Verified date December 2022
Source AlgoDx
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 304
Est. completion date November 1, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - The study will only include the subjects from the SEP-SE-02 study population. (NCT04570618) Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

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