Sensor-based congestion alert for people on peritoneal dialysis
Sensor-based Congestion Alert for Events in Peritoneal Dialysis (SCALE-PD)
This study tests whether the Bodyport Cardiac Scale can help predict worsening fluid overload events in adults receiving automated peritoneal dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Bodyport Inc. Industry-sponsored |
| Locations | 4 sites (Victorville, California and 3 other locations) |
| Trial ID | NCT07059962 on ClinicalTrials.gov |
What this trial studies
This observational study will collect repeated hemodynamic measurements using the Bodyport Cardiac Scale from adults on automated peritoneal dialysis who are followed on the Vantive Sharesource platform. Researchers will analyze individual biomarkers and composite indices, including an existing Congestion Index and a novel PD Index, to see which measurements correlate with clinical worsening from fluid overload. Data will be linked to clinical events over time to determine predictive patterns without altering participants' standard care. Enrollment focuses on adults able to stand unassisted and able to communicate in English or Spanish (with caregiver support as needed).
Who should consider this trial
Good fit: Ideal candidates are adults (21+) receiving automated peritoneal dialysis, followed on the Vantive Sharesource Remote Patient Management Platform, who can stand on the scale unassisted and communicate in English or Spanish (with caregiver assistance if needed).
Not a fit: Patients planning or expected to start hemodialysis or receive a transplant within 12 months, those with life expectancy under 12 months, pregnant people, those over the 375 lb weight limit, or those with implanted neurostimulator systems are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the device could enable earlier detection of fluid overload and reduce hospitalizations or urgent interventions for people on peritoneal dialysis.
How similar studies have performed: Sensor-based cardiac scale technologies have shown promise for detecting congestion in heart failure cohorts, but their application specifically to peritoneal dialysis patients is novel and less studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Victorville, California and 3 other locations
- Desert Cities Dialysis — Victorville, California, United States (Recruiting)
- Southeastern Clinical Research Institute — Augusta, Georgia, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Seven Oaks General Hospital — Winnipeg, Manitoba, Canada (Recruiting)
Study contacts
- Study coordinator: Corey Centen
- Email: corey@bodyport.com
- Phone: 415-990-5415
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.