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NCT Number: NCT07178470

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 (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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Fluid Overload Edema Lung Ultrasound POCUS Pathological Conditions, Signs and Symptoms Signs and Symptoms Volume Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Davita Home Dialysis of Indianapolis

Indianapolis, Indiana, 46260, United States

About this study

Participants will undergo the following assessments or procedures:

  • Review of medical records, including those from the dialysis center.
  • Blood pressure and weight measurement
  • Rate breathlessness
  • Physical Exam
  • Ultrasound procedure, during which the participant will lie flat on their back with their chest exposed. A small amount of gel will be applied to the skin, and a handheld ultrasound device will be pressed lightly to the chest. Eight specific areas on the chest will be imaged (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, study participation is complete.

We expect the entire study from enrollment to the completion of data collection for all subjects, to last 9 months. However, each participant will complete a single study visit, which will last for approximately 30-60 minutes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Consent: Inability to provide informed consent.
  • Inclusion Criteria: Not meeting any of the inclusion criteria.
  • Pregnancy.
  • Urgent-Start PD.
  • 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.

Treatment and study plan

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

Device

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 names: Ultrasound device either Phillips or Butterfly

Modified Medical Research Council (mMRC) Dyspnea scale

Other

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

physical exam

Other

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.

Primary outcomes

  1. Agreement between the LUS and physical exam

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    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.

  2. Agreement between the LUS and mMRC dyspnea scale

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will measure discordance and concordance between the LUS 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.

  3. Agreement between the physical exam and mMRc dyspnea scale.

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will measure discordance and concordance 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.

Secondary outcomes

  1. Correlation of mMRC dyspnea scale and blood pressure

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether a patient's subjective symptoms (such as their level of shortness of breath) gets worse in direct proportion to the patient's blood pressure. Blood pressure will be measured using an automated machine regularly used in the dialysis clinic.

  2. Correlation of mMRC dyspnea scale and weight

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether a patient's subjective symptoms (such as their level of shortness of breath) gets worse in direct proportion to the patient's weight. Weight will be measured using an automated machine regularly used in the dialysis clinic.

  3. Correlation of LUS and blood pressure

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether ultrasound scoring gets worse in direct proportion to blood pressure (i.e., does a higher B-line count correlate with higher blood pressure). Blood pressure will be measured using an automated machine regularly used in the dialysis clinic.

  4. Correlation of LUS and weight

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether ultrasound scoring gets worse in direct proportion to weight (i.e., does a higher B-line count correlate with higher weight). Weight will be measured using an automated machine regularly used in the dialysis clinic.

  5. Correlation of physical exam and blood pressure

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether physical exam assessment of volume status gets worse in direct proportion to blood pressure (i.e., does a higher volume overload correlate with higher blood pressure). Blood pressure will be measured using an automated machine regularly used in the dialysis clinic.

  6. Correlation of physical exam and weight

    Time frame: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed

    Researchers will evaluate whether physical exam assessment of volume status gets worse in direct proportion to weight (i.e., does a higher volume overload correlate with higher weight). Weight will be measured using an automated machine regularly used in the dialysis clinic.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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