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)

Not yet recruiting

• Conditions: Fluid Overload; POCUS; Lung Ultrasound; Volume Status

• Registration Number: NCT07178470
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

This study involves collecting information about you or from you. If you agree to be in the study, you will do your best to complete the following:

* Provide consent for us to review your medical records, including those from your dialysis center.

* The entire study visit will last for approximately 30-60 minutes including checking blood pressure, weight, questionnaire, doctor's visit and ultrasound

* We will measure blood pressure and weight if it's a part of your routine visit

* You will be given a questionnaire called modified medical research council dyspnea scale which includes only 1 question and anticipated to take less than a minute to answer

* After this, you will have your visit with your kidney doctor as usual. The doctor will assess how much excess fluid you might have by listening to your lungs and checking for swelling in your legs. They will not be given the results of the above survey.

After this, you'll go to a private room for the ultrasound procedure:

You'll lie flat on your back, and we'll expose your chest. A small amount of gel will be put on your skin, and we'll use a handheld ultrasound device to lightly press on your chest. We'll scan eight specific areas on your chest (four on each side) to look for something called "B-lines," which can show if there's extra fluid in your lungs. This ultrasound part of the visit should only take about 10 to 15 minutes in total.

Care will be taken to expose only the area being scanned. A chaperone (someone else in the room) will be present for all female patients. All male patients will be asked if they want a chaperone. If they say yes, a chaperone will be present during the ultrasound procedure. After the ultrasound, we'll wipe off the gel with a cloth, and you'll be ready to leave the room.

We expect the entire study from enrollment to the completion of data collection for all subjects, to last 9 months. However, your study visit will last only for 30-60minutes.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-17
• Last Update Posted: 2025-09-17
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age: Greater than 18 years.
2. Diagnosis: End-stage kidney disease (ESKD).
3. Treatment: Receiving home dialysis, either peritoneal dialysis (PD) or home hemodialysis (HHD).
4. Duration of Home Dialysis: At least three months on home dialysis.

Exclusion Criteria

1. Consent: Inability to provide informed consent.
2. Inclusion Criteria: Not meeting any of the inclusion criteria.
3. Pregnancy.
4. Urgent-Start PD.
5. Any other obvious cause of shortness of breath not related to volume overload including but not limited to pneumonia, pneumothorax, advanced COPD and Interstitial lung disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.	6-12 months	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. 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. Depending on the results additional analyses may be conducted to determine differences between peritoneal dialysis and home hemodialysis, or differences by sex, or differences by those on or off diuretics on those with and without residual renal function assessed by 24 hour urine output routinely done as part of standard care for the PD patients
discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.	Each participant will be involved in the study for 30-60 minutes which will include the questionnaire, physical examination, blood pressure, weight and ultrasound procedure.	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.