Diuretic Tuner Clinical Decision Support
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
This purpose of this study is to determine the effectiveness of a mobile phone application in helping to control body swelling in patients with kidney problems. The application will help in the day to day adjustments in diuretic medication dosing.
Participants in this study will have an application loaded on to their mobile phone by the study team and be taught how to use it over a 2 hour visit. Participants will need to check their blood pressure and weight daily and enter this information into the mobile phone application every day. Participants will need to follow daily instructions in their medication dosing provided by the application. There will be periodic blood testing. This will happen at 2 weeks, 90 days, and up to 4 other times if necessary. At the end of the study there is a 2 hour study visit during which participants will answer a survey. The total length of the study is 90 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The presence of nephrotic range proteinuria (> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or spot urine albumin/creatinine ratio) or stage 4 or 5 chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m2 by Modification of Diet in Renal Disease equation) PLUS
Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free weight without orthostatic hypotension) 5 lbs less than enrollment body weight
Disqualifiers
Weight < 100 lbs or > 300 lbs.
Autonomic insufficiency resulting in orthostatic hypotension at screening
Hypokalemia at enrollment (defined as serum potassium < 3.5 mmol/L)
Moderate to severe hyponatremia at enrollment (defined as serum sodium < 130 mmol/L)
Trial design
Design model
Single group
Treatments tested in this trial
Diuretic Tuner
DeviceMobile device application for diuretic dose titration
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Diuretic Tuner usersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean time to the attainment of dry weight
Mean time in days to the attainment of the provider-specified estimated dry weight
Time frame
90 days2
90 day weight variability
90 day weight variability around the target dry weight, as assessed by standard deviation
Time frame
90 daysSecondary outcomes
1
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
90 day adverse event rate for the composite outcome including hospitalization for volume-related complications (hypervolemia, hypovolemia, or electrolyte disturbance), hypokalemia (serum potassium \< 3.5 mmol/L), or acute renal insufficiency (serum creatinine ≥ 2 times baseline or \> 6 mg/dL)
Time frame
90 days2
Diuretic Tuner usability assessed by user survey
Diuretic tuner usability (measured by Likert scale survey administered to each subject at the end of 90 days)
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov