Use of Wearables to Detect Infections in Kidney Transplant Recipients

NCT ID: NCT06364618

Last Updated: 2024-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplant Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Ondřej Viklický, M.D., Ph.D.

Head of Transplantation Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute for Clinical and Experimental Medicine

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Vojtech Petr, MD

Role: CONTACT

720-639-0909

Facility Contacts

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Tereza Metelcova, PhD

Role: primary

+420261262125

Other Identifiers

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G-24-07

Identifier Type: -

Identifier Source: org_study_id

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