Use of Wearables to Detect Infections in Kidney Transplant Recipients

NCT06364618 | Not Yet Recruiting

• 1 other identifier: G-24-07
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Transplant Infection

Keywords

biometric data; continuous monitoring; machine learning; early alert system; infection; kidney transplantation

Outcome Measures

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.

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

Other Outcomes (2)

• Rate of in-patient admissions

  Periodically throughout the study, up to 24 months.

• Incidence of decrease/increase of Quality of Life

  Periodically throughout the study, up to 24 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• kidney transplant recipient
• age 18 years or more
• kidney allograft function (eGFR based on CKD-EPI more than 15ml/min/1.73m2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum at enrollment and then ad hoc at infection event

MeSH Terms

Conditions

Infections

Central Study Contacts

Vojtech Petr, MD

CONTACT

720-639-0909; petv@ikem.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Transplantation Center, Principal Investigator

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 15, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CZ (1)