Diuretic Tuner Clinical Decision Support

NCT04759274 | Recruiting FDA Device

• 1 other identifier: STU 2020-1124
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Edema; Hypervolemia; Chronic Kidney Diseases; Nephrotic Syndrome

Outcome Measures

Primary Outcomes (2)

• Mean time to the attainment of dry weight

  Mean time in days to the attainment of the provider-specified estimated dry weight

  90 days

• 90 day weight variability

  90 day weight variability around the target dry weight, as assessed by standard deviation

  90 days

Secondary Outcomes (2)

• Composite rate of hospitalization, hypokalemia, or acute renal insufficiency

  90 days

• Diuretic Tuner usability assessed by user survey

  90 days

Study Arms (1)

Diuretic Tuner users

EXPERIMENTAL

The Diuretic Tuner is a mobile device application that integrates a patient's estimated dry weight and starting diuretic dose (both defined by a healthcare provider) with daily weights and blood pressures to provide individualized guidance to the patient in day-to-day adjustments to his or her diuretic regimen. In addition, the application generates a diary of daily weights, blood pressures, fluid intake, and medication compliance.

Device: Diuretic Tuner

Interventions

Diuretic Tuner DEVICE

Mobile device application for diuretic dose titration

Diuretic Tuner users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Serum creatinine \> 6 mg/dL or \> 1.5 times baseline
• Patients who are unable or unwilling to measure their home blood pressures and weights
• Patients without a working phone number and smart phone device
• Expectation that the patient will require dialysis initiation within \< 3 months
• Expected lifespan of \< 6 months
• The presence of a medical condition that would interfere with effectively using the Diuretic Tuner (dementia, illiteracy, or blindness)
• Pregnant patients
• Prisoners

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Conditions

Edema; Renal Insufficiency, Chronic; Nephrotic Syndrome

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Nephrosis

Central Study Contacts

Kamalanathan K Sambandam, M.D.

CONTACT

214-645-6190; ksambandam@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 18, 2021
• Study Start: November 20, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)