Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bodyport Cardiac Scale.
- Who it may be relevant to
- Registry conditions: Kidney Disease, Peritoneal Dialysis (PD), End Stage Kidney Disease (ESRD). Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
Overview
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.
Detailed 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.
Interventions
- Device Bodyport Cardiac Scale
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 outcome measures
- Sensitivity Analysis [Time frame: 1 year]
Secondary outcome measures (1)
- Peritoneal Dialysis (PD) Events [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Desert Cities Dialysis — Victorville
- Southeastern Clinical Research Institute — Augusta
- Northwestern University — Chicago
Canada · 1 center
- Seven Oaks General Hospital — Winnipeg
Identifiers
NCT: NCT07059962 · CP-ScalePD-01