Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorBodyport Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Males and females 21 years of age or older, with end stage kidney disease undergoing peritoneal dialysis.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bodyport Cardiac Scale
DeviceThe Bodyport Cardiac Scale captures several physiological signals, which are used to derive multiple biomarkers that reflect a user's hemodynamic and fluid status.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: PD Patients1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity Analysis
Sensitivity for predicting usable PDE \> 0.40 and an alert rate of \< 4.3 alerts per patient-year.
Time frame
1 yearSecondary outcomes
1
Peritoneal Dialysis (PD) Events
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.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov