Use of Wearables to Detect Infections in Kidney Transplant Recipients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitute for Clinical and Experimental Medicine

About this trial

The goal of this observational study is to develop a machine learning algorithm for early detection of infections in kidney transplant recipients using data recorded by wearable digital health technologies.

The main questions it aims to answer are:

1. What are the biometric data pattern changes in impending infections? 2. What accuracy the machine learning algorithm can achieve?

Participants will be given/use their own wearable device that will record biometric data. Any infection event will be recorded and an algorithm will be trained to recognize changes in biometric data preceding symptomatic infection.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

kidney transplant recipient

age 18 years or more

kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)

Disqualifiers

recipient of another transplanted organ

terminal failure of another organ (heart, liver, lung)

diabetes mellitus type 1

pregnant or breastfeeding woman

Trial population

Kidney transplant recipients followed at the Institute for Clinical and Experimental Medicine.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Accuracy of the algorithm at detecting infections at presymptomatic stage

Accuracy, sensitivity, specificity, negative and positive predictive value of the machine learning algorithm at detecting infections in presymptomatic stage in kidney transplant recipients.

Time frame
The primary endpoint will be assessed periodically throughout the study, up to 24 months.

Secondary outcomes

Other outcomes

1

Rate of in-patient admissions

Any hospital admission for infection treatment is considered an event of this outcome

Time frame
Periodically throughout the study, up to 24 months.
2

Incidence of decrease/increase of Quality of Life

Score change of WHOQOL-BREF from baseline.

Time frame
Periodically throughout the study, up to 24 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: