Early Warning of Intradialytic Hypotension in Hemodialysis Patients

NCT ID: NCT04680039

Last Updated: 2022-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-15

Study Completion Date

2022-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Hypotension of Hemodialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Continuous monitoring

Identifying intradialytic hypotension using a PPG-based wearable monitor

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biobeat Technologies Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Nachman, MD

Role: PRINCIPAL_INVESTIGATOR

The Hadassah Ein Kerem Medical Center, Jerusalem, Israel

Locations

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The Hadassah Ein Kerem Medical Center

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PPGESKD001

Identifier Type: -

Identifier Source: org_study_id

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