Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Diseases
  • Edema
  • Hypervolemia
  • Nephrotic Syndrome
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5. Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in t...

Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5. Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in the study population. The Diuretic Tuner will integrate each subject's estimated dry weight and starting diuretic dose (both defined by healthcare provider) with daily weights and blood pressures to provide individualized guidance to the subject in day-to-day adjustments to his or her diuretic regimen. In addition, the application will generate a diary of daily weights, blood pressures, fluid intake, and medication compliance. There will be no control arm as this first phase is to test feasibility/safety. Study Outcome Measures: The primary outcomes of interest will focus on the achievement of the provider-defined estimated dry weight (both the time to achieving this target as well as the subsequent stability in weights around this target). Secondary outcomes of interest include safety metrics (3-month hospitalization rates, rates of hypokalemia, and rates of acute kidney injury) and tool usability (assessed through surveys evaluating ease of comprehension and satisfaction).

Tracking Information

NCT #
NCT04759274
Collaborators
Not Provided
Investigators
Not Provided