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NCT Number: NCT06364618

Use of Wearables to Detect Infections in Kidney Transplant Recipients

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.

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Key information

Conditions

Kidney Transplant Infection Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location contact

Ivan Zahradka, MD

PRINCIPAL_INVESTIGATOR

Katarina Jakubov, MD

SUB_INVESTIGATOR

Tereza Metelcova, PhD

CONTACT

[email protected]

+420261262125

Vojtech Petr, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

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

Other outcomes

  1. Rate of in-patient admissions

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

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

  2. Incidence of decrease/increase of Quality of Life

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

    Score change of WHOQOL-BREF from baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Vojtech Petr, MD

CONTACT

[email protected]

720-639-0909

Sponsors and collaborators

Lead sponsor

Institute for Clinical and Experimental Medicine

Other Gov

Registry information

Official study title

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

Acronym: RENALERT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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