Early Warning of Intradialytic Hypotension in Hemodialysis Patients

Biobeat

Status: Completed

Conditions: Hypotension of Hemodialysis

Treatments: Device: Continuous monitoring

Study type: Observational

Funder types: Industry

Identifiers

NCT04680039

PPGESKD001

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No 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.