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NCT07178470 · ClinicalTrials.gov registry record
Concordance and Discordance in the Assessment of Volume Status in Home Dialysis Patients: A Comparison of Modified Medical Research Council Dyspnea Scale, Physical Exam, and Point of Care Ultrasound (POCUS)
A clinical trial of Fluid Overload and POCUS, sponsored by Indiana University.
- Recruiting
- Registry status
- 90
- Enrollment target
- 1
- Study location
NCT07178470: Recruiting study of Fluid Overload and POCUS, sponsored by Indiana University.
NCT07178470 is a study of Fluid Overload and POCUS that is actively recruiting participants, run by Indiana University. The registered enrollment target is 90 participants, below the 150-participant average among 8 other Fluid Overload trials with a reported enrollment target (40% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07178470, a study of Fluid Overload and POCUS, is actively recruiting participants, sponsored by Indiana University.
- RECRUITING
- Registry status
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
Fluid overload, which is when your body has too much fluid, is one of the reasons why people on home dialysis need to go to the hospital. Fluid overload (when body has too much fluid) commonly presents as trouble breathing and leg swelling. Traditionally, doctors check for this by asking patients if they have any symptoms like leg swelling or shortness of breath and by doing a physical exam which includes listening to the lungs or looking for swelling in legs. However, a newer, safe, and non-invasive method called point-of-care ultrasound (POCUS) has become very popular. However, we don't have a lot of research yet on how POCUS and LUS (lung ultrasound) specifically help home dialysis patients, including those on peritoneal dialysis or home hemodialysis. Peritoneal dialysis is a way to clean your blood by putting a special fluid into your belly through a small tube. The fluid uses the natural lining of your belly as a filter to remove waste and extra water. Home hemodialysis is a treatment where a machine acts like an artificial kidney to clean your blood. You get trained to do this yourself at home by connecting to the machine with a couple of needles, which cleans your blood of waste and extra fluid. POCUS, especially a (LUS), has been shown to be useful for dialysis patients in outpatient units. This study will compare different 3 different methods of detecting fluid overload: answering various survey questions, completing a physical exam, and a LUS. The study seeks to determine which of these methods is the best method to determine fluid overload. You were selected as a possible participant because you are over 18 years old, diagnosed with End-stage kidney disease, and have been receiving home dialysis for at least three months.
Primary Outcome
Researchers will measure discordance and concordance between the LUS and physical exam. A pair is concordant if the observation ranking higher on one variable also ranks higher on the second measure. The pair is discordant if the observation ranking higher on one endpoint measure and ranks lower on the other. The pair is tied if the subjects have the same classification on both measures.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination
Study Locations (1)
Indiana
- Davita Home Dialysis of Indianapolis - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2026-01-09 |
| Est. Completion | 2026-06 |
What NCT07178470 shows while recruiting
NCT07178470 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 150-participant average among 8 other Fluid Overload trials with a reported enrollment target (40% lower).
The record links to 4 conditions, with Fluid Overload appearing as the primary indexed condition, and to 1 intervention - of which Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination is the first listed.
NCT07178470 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT07178470 about?
NCT07178470 is a clinical study titled "Concordance and Discordance in the Assessment of Volume Status in Home Dialysis Patients: A Comparison of Modified Medical Research Council Dyspnea Scale, Physical Exam, and Point of Care Ultrasound (POCUS)". Fluid overload, which is when your body has too much fluid, is one of the reasons why people on home dialysis need to go to the hospital. Fluid overload (when body has too much fluid) commonly presents as trouble breathing and leg swelling. Traditionally, doctors check for this by asking patients if...
What is the current status of trial NCT07178470?
This trial is currently recruiting. The enrollment target is 90 participants. The study started on 2026-01-09. Estimated completion is 2026-06.
What conditions does trial NCT07178470 study?
This clinical trial studies the following conditions: Fluid Overload, POCUS, Lung Ultrasound, Volume Status.
What interventions are being tested in trial NCT07178470?
The interventions under investigation include: Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07178470?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07178470 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07178470's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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