Early Warning of Intradialytic Hypotension in Hemodialysis Patients

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

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 Overview

• Status: Completed
• Conditions: Hypotension of Hemodialysis
• Intervention / Treatment: Device: Continuous monitoring

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • The Hadassah Ein Kerem Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

150 adult subjects (≥18 years) with end stage kidney disease (ESKD) undergoing chronic hemodialysis (HD) treatments in Hadassah Ein-Kerem medical center. A patient can participate more than once.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with intradialytic hypotension	Using a PPG-based non-invasive wearable monitor to allow early detection of intradialytic hypotension	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining the pathogenesis of intradialytic hypotension	Continuous monitoring of numerous hemodynamic parameters will allow to determine the pathogenesis	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Biobeat Technologies Ltd.
• Investigators: Principal Investigator: Dean Nachman, MD, The Hadassah Ein Kerem Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): February 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hemodialysis; Intradialytic hypotension; Remote Monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: PPGESKD001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No