Early Warning of Intradialytic Hypotension in Hemodialysis Patients

NCT04680039 | Completed FDA Device

• 1 other identifier: PPGESKD001
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension of Hemodialysis

Keywords

Hemodialysis; Intradialytic hypotension; Remote Monitoring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determining the pathogenesis of intradialytic hypotension

  Through study completion, an average of 1 year.

Interventions

Continuous monitoring DEVICE

Identifying intradialytic hypotension using a PPG-based wearable monitor

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biobeat Technologies Ltd.: lead

Study Sites (1)

The Hadassah Ein Kerem Medical Center

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Dean Nachman, MD

  The Hadassah Ein Kerem Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 22, 2020
• Study Start: January 15, 2021
• Primary Completion: February 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

IL (1)