Actively Recruiting
Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
Led by University of Texas Southwestern Medical Center · Updated on 2025-09-16
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile phone application called the Diuretic Tuner to help control body swelling in patients with kidney problems, specifically those with hypervolemia due to nephrotic syndrome or advanced chronic kidney disease (stage 4 or 5). This nonrandomized, uncontrolled trial aims to test the feasibility and safety of using this app to assist patients in adjusting their diuretic medication daily based on their weight and blood pressure. The study is sponsored by the University of Texas Southwestern Medical Center and focuses on achieving and maintaining an estimated dry weight without excess fluid. Participants will have the Diuretic Tuner application installed on their smartphones during a 2-hour visit where they will also learn how to use it. The app integrates each patient's estimated dry weight and starting diuretic dose, both defined by their healthcare provider, with daily weight and blood pressure measurements entered by the patient. The app provides daily personalized dosing instructions and creates a diary tracking weights, blood pressure, fluid intake, and medication adherence. Blood tests will be done at 2 weeks, 90 days, and up to four additional times if needed. The total study duration is 90 days, ending with a final 2-hour visit to complete a survey about the app's usability. During the study, participants will monitor their blood pressure and weight every day and enter this data into the app. Researchers will assess how quickly and stably participants reach their target dry weight over 90 days. They will also monitor safety outcomes including hospitalization rates, low potassium levels, and kidney function changes. Usability of the Diuretic Tuner app will be evaluated through participant surveys. The study involves close monitoring with periodic lab tests and a final visit for feedback, helping researchers understand the app’s potential to support self-management of fluid control in kidney disease.
CONDITIONS
Brief Title
Diuretic Tuner Clinical Decision Support
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Presence of nephrotic range proteinuria (> 3 g/day) or stage 4 or 5 chronic kidney disease (eGFR < 30 mL/min/1.73 m2)
- Clinical signs of hypervolemia such as lower limb edema, ascites, or pleural effusions
- Estimated dry weight at least 5 lbs less than enrollment body weight
You will not qualify if you...
- Weight less than 100 lbs or more than 300 lbs
- Autonomic insufficiency causing orthostatic hypotension
- Hypokalemia at enrollment (serum potassium < 3.5 mmol/L)
- Moderate to severe hyponatremia at enrollment (serum sodium < 130 mmol/L)
- Serum creatinine > 6 mg/dL or more than 1.5 times baseline
- Unable or unwilling to measure blood pressure and weight at home
- No working phone number or smartphone device
- Expected dialysis initiation within less than 3 months
- Expected lifespan less than 6 months
- Medical conditions interfering with app use (dementia, illiteracy, blindness)
- Pregnant patients
- Prisoners
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 90 days
Participants use the Diuretic Tuner mobile device application to receive individualized guidance for daily adjustments to their diuretic regimen based on their estimated dry weight, daily weights, and blood pressures. The app also generates a diary of daily weights, blood pressures, fluid intake, and medication compliance.
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
K
Kamalanathan K Sambandam, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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