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)

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07178470
Status
Recruiting
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Conditions

  • Fluid Overload
  • Lung Ultrasound
  • POCUS
  • Volume Status

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Jan 9, 2026
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Only a single cohort/group
    This study includes only one group all of whom get the same testing

Primary Outcome 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. [ Time Frame: 6-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Davita Home Dialysis of IndianapolisIndianapolisIndiana46260

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By research site
Davita Home Dialysis of Indianapolis· Indianapolis, IN

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