RECRUITING

Diuretic Tuner Clinical Decision Support

Conditions

Edema Hypervolemia Chronic Kidney Diseases Nephrotic Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States

Quick Facts

Study Start:2023-11-20

Study Completion:2026-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04759274

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Kamalanathan K Sambandam, M.D.

CONTACT

214-645-6190

ksambandam@utsouthwestern.edu

Study Locations (Sites)

University of Texas Southwestern

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20

Study Completion Date2026-08

Study Record Updates

Study Start Date2023-11-20

Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

Edema
Hypervolemia
Chronic Kidney Diseases
Nephrotic Syndrome