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OpenTrials
Completed

NCT Number: NCT04680039

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.

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Key information

Conditions

Hypotension of Hemodialysis

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hadassah Ein Kerem Medical Center

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Continuous Monitoring

Device

Identifying intradialytic hypotension using a PPG-based wearable monitor

Primary outcomes

  1. Number of participants with intradialytic hypotension

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

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

Secondary outcomes

  1. Determining the pathogenesis of intradialytic hypotension

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

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

Sponsors and collaborators

Lead sponsor

Biobeat Technologies Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 22, 2020
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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