Noninvasive Hemodynamic Parameters Measurements as a Tool for Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Biobeat Technologies Ltd.1 site in 1 country150 target enrollmentJanuary 15, 2021

ConditionsHypotension of Hemodialysis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Hypotension of Hemodialysis
Sponsor: Biobeat Technologies Ltd.
Enrollment: 150
Locations: 1
Primary Endpoint: Number of participants with intradialytic hypotension
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the investigators will monitor patients undergoing hemodialysis treatment with a non-invasive wearable PPG-based device. Measurements will include blood pressure, heart rate, oxygen saturation, stroke volume, cardiac output, cardiac index and systemic vascular resistance, among others. The aim is to diagnose intradialytic hypotension more rapidly than with current noninvasive methods and prevent related poor outcomes.

Registry

clinicaltrials.gov

Start Date

January 15, 2021

End Date

March 15, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Biobeat Technologies Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with EKSD undergoing chronic hemodialysis treatments for \> 3 months.
•Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study.
•Patients must satisfy a medical examiner about their fitness to participate in the study.
•Patients must provide written informed consent to participate in the study.

Exclusion Criteria

•Patients with an inability to communicate well with the Principal investigator (PI) and staff (i.e., language problem, poor mental development, or impaired cerebral function).
•Withholding the dialysis session for any reason prior to initiation.
•Minors under the age of 18.