Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Hypotension of Hemodialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680039
• Other study ID #: PPGESKD001
• Status: Completed
• Start date: January 15, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: July 2022
• Source: Biobeat Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 15, 2022
• Est. primary completion date: February 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Hypotension of Hemodialysis

Intervention

Device:
• Continuous monitoring
Identifying intradialytic hypotension using a PPG-based wearable monitor

Locations

Country	Name	City	State
Israel	The Hadassah Ein Kerem Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Biobeat Technologies Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determining the pathogenesis of intradialytic hypotension	Continuous monitoring of numerous hemodynamic parameters will allow to determine the pathogenesis	Through study completion, an average of 1 year.