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Status:

RECRUITING

Diuretic Tuner Clinical Decision Support

Lead Sponsor:

University of Texas Southwestern Medical Center

Conditions:

Edema

Hypervolemia

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Detailed Description

Study Population: 30 subjects with signs of hypervolemia and either nephrotic syndrome or chronic kidney disease 4 to 5. Study Intervention: This is a nonrandomized, uncontrolled trial. The Diuretic ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 20 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04759274

Start Date

November 20 2023

End Date

August 1 2026

Last Update

September 16 2025

Active Locations (1)

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1

University of Texas Southwestern

Dallas, Texas, United States, 75390