Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)

Bodyport

Status: Enrolling

Conditions: Peritoneal Dialysis (PD); End Stage Kidney Disease (ESRD); Kidney Disease

Treatments: Device: Bodyport Cardiac Scale

Study type: Observational

Funder types: Industry

Identifiers

NCT07059962

CP-ScalePD-01

Details and patient eligibility

About

To explore the use of the Bodyport Cardiac Scale in predicting worsening of events due to fluid overload in patients with kidney disease on peritoneal dialysis.

Full description

The objective of this study is to explore the utility of hemodynamic biomarkers measured by the Bodyport Cardiac Scale in predicting worsening events attributable to fluid overload among those with kidney disease on peritoneal dialysis. The study will explore individual biomarkers, as well as composite biomarker indices, such as the Congestion Index and a novel PD Index.

Enrollment: 125 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 21 years or older
2. Able to speak and read English, or able to speak and read Spanish and has a caregiver or family member who speaks English and can provide assistance
3. Able to stand on two bare feet unassisted
4. Receiving automated peritoneal dialysis for the treatment of ESKD
5. Followed on the Vantive Sharesource Remote Patient Management Platform

Exclusion criteria

1. Undergoing or plan to undergo hemodialysis in the next 12 months
2. Have a life expectancy of less than 12 months
3. Are pregnant or plan to become pregnant during the next 12 months
4. Weigh greater than 375 lbs
5. Planned kidney transplant within the next 12 months
6. Have an implanted neurostimulator system

Trial design

125 participants in 1 patient group

PD Patients

Description:

Patients with kidney disease on peritoneal dialysis.

Treatment:

Device: Bodyport Cardiac Scale