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ACTIVE NOT RECRUITING
NCT07178470
NA

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)

Sponsor: Indiana University

View on ClinicalTrials.gov

Summary

Fluid overload (when the body has too much fluid), is one of the reasons why people on home dialysis need to go to the hospital. Fluid overload 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, there is not 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 the blood by putting a special fluid into the abdomen through a small tube. The fluid uses the natural lining of the 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 the blood. Patients get trained to do this themselves at home by connecting to the machine with a couple of needles, which cleans their 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 in adult patients with End-stage kidney disease who are receiving home dialysis: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-01-09

Completion Date

2026-11-30

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DEVICE

point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS)

An eight-zone scanning protocol will be used to count the number of B-lines. Patients will be assigned a score based on the B-line count and categorized as absent, mild, moderate, or severe for fluid overload

OTHER

Modified Medical Research Council (mMRC) Dyspnea scale

The Modified Medical Research Council (mMRC) Dyspnea scale will be administered to patients to assess patient symptoms, with scores ranging from 0 to +4.

OTHER

Physical Exam

Clinicians will perform a physical examination using standard practices to assess for signs of fluid overload, including lower extremity edema, crackles on auscultation, weight gain, and vital signs. Patients will then be categorized as hypovolemic, euvolemic, mild, moderate, or severe volume overloaded. The physicians will be blinded to the patient reported symptoms and the LUS.

Locations (1)

Davita Home Dialysis of Indianapolis

Indianapolis, Indiana, United States