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)
NCT07178470 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 90
Last updated 2026-02-27
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.
Conditions
- Fluid Overload
- POCUS
- Lung Ultrasound
- Volume Status
Interventions
- DIAGNOSTIC_TEST
-
Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination
After obtaining informed consent, the Modified Medical Research Council (mMRC) Dyspnea scale will be administered to patients, and their responses will be recorded on a scale of 0 to +4. During the same clinical visit, a physical examination will be performed by the primary nephrologist, who will categorize the patient's volume status as hypovolemic, euvolemic, mild, moderate, or severe volume overloaded. Finally, point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS), will be performed. Patients will be assigned a score based on the number of B-lines observed. We will measure discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.
Sponsors & Collaborators
-
Indiana University
lead OTHER
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-09
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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