Use of Wearables to Detect Infections in Kidney Transplant Recipients

Kidney Transplant Infection Clinical Trial

— RENALERT  

Official title:

Use of Continuous Biomonitoring for Detection of Infectious Complications in Kidney Transplant Recipients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06364618
• Other study ID #: G-24-07
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: April 2024
• Source: Institute for Clinical and Experimental Medicine
• Contact: Vojtech Petr, MD
• Phone: 720-639-0909
• Email: petv[@]ikem.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Kidney Transplant Infection

Locations

Country	Name	City	State
Czechia	Institute for Clinical and Experimental Medicine	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Institute for Clinical and Experimental Medicine

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of in-patient admissions	Any hospital admission for infection treatment is considered an event of this outcome	Periodically throughout the study, up to 24 months.
Other	Incidence of decrease/increase of Quality of Life	Score change of WHOQOL-BREF from baseline.	Periodically throughout the study, up to 24 months.
Primary	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.	The primary endpoint will be assessed periodically throughout the study, up to 24 months.