Use of Wearables to Detect Infections in Kidney Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kidney Transplant Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients
Overview
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.
Primary outcome measures
- Accuracy of the algorithm at detecting infections at presymptomatic stage [Time frame: The primary endpoint will be assessed periodically throughout the study, up to 24 months.]
Eligibility criteria
Inclusion criteria
- kidney transplant recipient
- age 18 years or more
- kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)
Exclusion criteria
- recipient of another transplanted organ
- terminal failure of another organ (heart, liver, lung)
- diabetes mellitus type 1
- pregnant or breastfeeding woman
- refusal to give informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Czechia · 1 center
- Institute for Clinical and Experimental Medicine — Prague
Identifiers
NCT: NCT06364618 · G-24-07