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

December 12, 2022 updated by: AlgoDx
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Intensiv- och perioperativ vård

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult ICU patient population

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction performance of NAVOY® AKI
Time Frame: 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.
Data from ICU stay between December 2020 to October 2021.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlgoDx

Investigators

  • Principal Investigator: Fredrik Sjövall, MD PhD, Skanes universitetssjukhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

June 2, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKI-SE-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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