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Diuretic Tuner Clinical Decision Support

Primary Purpose

Edema, Hypervolemia, Chronic Kidney Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diuretic Tuner
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diuretic Tuner users

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean time to the attainment of dry weight
Mean time in days to the attainment of the provider-specified estimated dry weight
90 day weight variability
90 day weight variability around the target dry weight, as assessed by standard deviation

Secondary Outcome Measures

Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
90 day adverse event rate for the composite outcome including hospitalization for volume-related complications (hypervolemia, hypovolemia, or electrolyte disturbance), hypokalemia (serum potassium < 3.5 mmol/L), or acute renal insufficiency (serum creatinine ≥ 2 times baseline or > 6 mg/dL)
Diuretic Tuner usability assessed by user survey
Diuretic tuner usability (measured by Likert scale survey administered to each subject at the end of 90 days)

Full Information

First Posted
February 9, 2021
Last Updated
August 28, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04759274
Brief Title
Diuretic Tuner Clinical Decision Support
Official Title
Diuretic Tuner Clinical Decision Support Mobile Device Application for Diuretic Titration in Hypervolemic States
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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 Tuner mobile device application will be deployed in the care of hypervolemic subjects as defined in the study population. The Diuretic Tuner will integrate each subject's estimated dry weight and starting diuretic dose (both defined by healthcare provider) with daily weights and blood pressures to provide individualized guidance to the subject in day-to-day adjustments to his or her diuretic regimen. In addition, the application will generate a diary of daily weights, blood pressures, fluid intake, and medication compliance. There will be no control arm as this first phase is to test feasibility/safety. Study Outcome Measures: The primary outcomes of interest will focus on the achievement of the provider-defined estimated dry weight (both the time to achieving this target as well as the subsequent stability in weights around this target). Secondary outcomes of interest include safety metrics (3-month hospitalization rates, rates of hypokalemia, and rates of acute kidney injury) and tool usability (assessed through surveys evaluating ease of comprehension and satisfaction).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edema, Hypervolemia, Chronic Kidney Diseases, Nephrotic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diuretic Tuner users
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diuretic Tuner
Intervention Description
Mobile device application for diuretic dose titration
Primary Outcome Measure Information:
Title
Mean time to the attainment of dry weight
Description
Mean time in days to the attainment of the provider-specified estimated dry weight
Time Frame
90 days
Title
90 day weight variability
Description
90 day weight variability around the target dry weight, as assessed by standard deviation
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Composite rate of hospitalization, hypokalemia, or acute renal insufficiency
Description
90 day adverse event rate for the composite outcome including hospitalization for volume-related complications (hypervolemia, hypovolemia, or electrolyte disturbance), hypokalemia (serum potassium < 3.5 mmol/L), or acute renal insufficiency (serum creatinine ≥ 2 times baseline or > 6 mg/dL)
Time Frame
90 days
Title
Diuretic Tuner usability assessed by user survey
Description
Diuretic tuner usability (measured by Likert scale survey administered to each subject at the end of 90 days)
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamalanathan K Sambandam, M.D.
Phone
214-645-6190
Email
ksambandam@utsouthwestern.edu
Facility Information:
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamalanathan K Sambandam
Phone
469-441-7181
Email
ksambandam@utsouthwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Diuretic Tuner Clinical Decision Support

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