Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Biobeat Technologies Ltd.150 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Hypotension of Hemodialysis

Interventions

Continuous monitoringDEVICE

Identifying intradialytic hypotension using a PPG-based wearable monitor

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with EKSD undergoing chronic hemodialysis treatments for \> 3 months. 2. Patients must be able to adhere to the visit schedule and protocol requirements and be available to complete the study. 3. Patients must satisfy a medical examiner about their fitness to participate in the study. 4. Patients must provide written informed consent to participate in the study. Exclusion Criteria: 1. 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). 2. Withholding the dialysis session for any reason prior to initiation. 3. Minors under the age of 18.

Locations (1)

The Hadassah Ein Kerem Medical Center

Jerusalem, Israel

Outcomes

Primary Outcomes

Number of participants with intradialytic hypotension

Using a PPG-based non-invasive wearable monitor to allow early detection of intradialytic hypotension

Time frame: Through study completion, an average of 1 year.

Secondary Outcomes

Determining the pathogenesis of intradialytic hypotension

Continuous monitoring of numerous hemodynamic parameters will allow to determine the pathogenesis

Time frame: Through study completion, an average of 1 year.

Data from ClinicalTrials.gov

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