BridgeMD
New treatment option for Edema
Official title Diuretic Tuner Clinical Decision Support
ClinicalTrials.gov ID: NCT04759274
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The presence of nephrotic range proteinuria (\> 3 g/d proteinuria by 24hr urine protein, 24hr urine albumin, spot urine protein/creatinine ratio, or...
- Clinical signs of hypervolemia present (lower extremity edema, ascites, or pleural effusions) with an estimated dry weight (defined as edema-free...
You likely can't join if
- Weight \ 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
See the full eligibility 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...
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Dallas, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dallas, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.