NCT05424874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
Last Updated

December 13, 2022

Status Verified

December 1, 2022

Enrollment Period

11 months

First QC Date

June 2, 2022

Last Update Submit

December 12, 2022

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ICU patient population

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensiv- och perioperativ vård

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Fredrik Sjövall, MD PhD

    Skånes Universitetssjukhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 21, 2022

Study Start

December 2, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

December 13, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)