Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Completed

• Conditions: Hypotension of Hemodialysis

• Registration Number: NCT04680039
• Lead Sponsor: Biobeat Technologies Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-20
• Study First Posted: 2020-12-22
• Study Start: 2021-01-15
• Primary Completion: 2022-02-15
• Study Completion: 2022-03-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hadassah Ein Kerem Medical Center; 🇮🇱 Jerusalem, Israel