End Stage Kidney Disease (ESRD), Kidney Disease, Peritoneal Dialysis (PD)
Conditions
Keywords
kidney disease, peritoneal dialysis, fluid overload, heart failure
Brief summary
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
DEVICEBodyport 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.
Sponsors
Bodyport Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity Analysis | 1 year | Sensitivity for predicting usable PDE \> 0.40 and an alert rate of \< 4.3 alerts per patient-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peritoneal Dialysis (PD) Events | 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. |
Countries
Canada, United States
Contacts
CONTACTCorey Centen
CONTACTDorothy Kwok
Outcome results
None listed