Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Last updated: July 19, 2022
Sponsor: Biobeat Technologies Ltd.
Overall Status: Completed

Phase

N/A

Condition

Circulation Disorders

Dizzy/fainting Spells

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04680039
PPGESKD001
  • Ages 18-120
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 beavailable to complete the study.
  3. Patients must satisfy a medical examiner about their fitness to participate in thestudy.
  4. Patients must provide written informed consent to participate in the study.

Exclusion

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 cerebralfunction).
  2. Withholding the dialysis session for any reason prior to initiation.
  3. Minors under the age of 18.

Study Design

Total Participants: 150
Study Start date:
January 15, 2021
Estimated Completion Date:
March 15, 2022

Connect with a study center

  • The Hadassah Ein Kerem Medical Center

    Jerusalem, 91120
    Israel

    Site Not Available

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