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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Kidney Disease Cardiovascular Diseases Chronic Disease Disease Attributes Edema End Stage Kidney Disease (ESRD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Dialysis (PD) Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seven Oaks General Hospital, Winnipeg, Manitoba, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 21 years or older
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
Able to stand on two bare feet unassisted
Receiving automated peritoneal dialysis for the treatment of ESKD
Followed on the Vantive Sharesource Remote Patient Management Platform

Exclusion criteria

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

Treatment and study plan

Bodyport Cardiac Scale

Device

The Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.

Primary outcomes

Sensitivity Analysis

Time frame: 1 year

Sensitivity for predicting usable PDE > 0.40 and an alert rate of < 4.3 alerts per patient-year.

Secondary outcomes

Peritoneal Dialysis (PD) Events

Time frame: 1 year

Collection of approximately 40 usable PD Events for model development and validation. These events are defined as urgent, unscheduled clinic visits or emergency department visits or hospital admissions for worsening fluid overload and initiation or intensification of treatment for fluid overload or termination of treatment due to fluid related cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Corey Centen

CONTACT

[email protected]

415-990-5415

Dorothy Kwok

CONTACT

[email protected]

669-240-3077

Sponsors and collaborators

Lead sponsor

Bodyport Inc.

Industry

Registry information

Acronym: SCALE-PD

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 11, 2025
Registry last updated: Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting