Diuretic Tuner Clinical Decision Support

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Feb 14, 2021

Keywords

ClinConnect Summary

The Diuretic Tuner Clinical Decision Support trial is studying how a mobile phone application can help patients with kidney problems manage body swelling, which can happen due to conditions like chronic kidney disease or nephrotic syndrome. The app will guide users on how to adjust their diuretic medications, which are medicines that help remove extra fluid from the body. To participate, individuals should have specific signs of fluid overload, such as swelling in the legs or abdomen, and must have certain levels of protein in their urine or advanced kidney disease. They also need to be able to measure their weight and blood pressure at home daily.

Participants will receive training on using the app during a two-hour visit and will need to check in regularly for blood tests throughout the 90-day study. At the end, there will be another two-hour visit to complete a survey about their experience. It's important to note that individuals who weigh less than 100 pounds or more than 300 pounds, or who have certain health conditions, may not qualify for the study. This trial offers a chance to potentially improve fluid management in kidney disease patients through technology.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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