Early Warning of Intradialytic Hypotension in Hemodialysis Patients

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04680039

Enrollment

150

Registered

2020-12-22

Start date

2021-01-15

Completion date

2022-03-15

Last updated

2022-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension of Hemodialysis

Keywords

Hemodialysis, Intradialytic hypotension, Remote Monitoring

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.

Interventions

DEVICEContinuous monitoring

Identifying intradialytic hypotension using a PPG-based wearable monitor

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026