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 | Recruiting FDA Device

• 1 other identifier: 28387
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Ultrasound; Volume Status; Fluid Overload; POCUS

Keywords

pocus; fluid overload; lung ultrasound; volume status; modified Medical Research Council Dyspnea Scale; mMRC dyspnea scale

Outcome Measures

Primary Outcomes (2)

• Discordance and concordance between the LUS and physical exam, the LUS and mMRC dyspnea scale, and between the physical exam and mMRc dyspnea scale.

  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

  6-12 months

• 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.

  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.

Study Arms (1)

Only a single cohort/group

This study includes only one group all of whom get the same testing

Diagnostic Test: Modified Medical Research Council (mMRC) Dyspnea scale , , point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS) and physical examination

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.

Also known as: Ultrasound device either Phillips or Butterfly

Only a single cohort/group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All home dialysis patient's at DaVita Home Dialysis of Indianapolis who are on home dialysis including peritoneal and home hemodialysis will be potential candidates

You may qualify if:

• 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.

You may not qualify if:

• Consent: Inability to provide informed consent.
• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Davita Home Dialysis of Indianapolis

Indianapolis, Indiana, 46260, United States

RECRUITING

Related Publications (5)

• Leidi A, Soret G, Mann T, Koegler F, Coen M, Leszek A, Dubouchet L, Guillermin A, Kaddour M, Rouyer F, Combescure C, Carballo S, Reny JL, Marti C, Stirnemann J, Grosgurin O. Eight versus 28-point lung ultrasonography in moderate acute heart failure: a prospective comparative study. Intern Emerg Med. 2022 Aug;17(5):1375-1383. doi: 10.1007/s11739-022-02943-9. Epub 2022 Feb 18.

  PMID: 35181839 BACKGROUND

• Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.

  PMID: 3342669 BACKGROUND

• Alexandrou ME, Theodorakopoulou MP, Sarafidis PA. Lung Ultrasound as a Tool to Evaluate Fluid Accumulation in Dialysis Patients. Kidney Blood Press Res. 2022;47(3):163-176. doi: 10.1159/000521691. Epub 2022 Jan 10.

  PMID: 35008093 BACKGROUND

• Maw AM, Hassanin A, Ho PM, McInnes MDF, Moss A, Juarez-Colunga E, Soni NJ, Miglioranza MH, Platz E, DeSanto K, Sertich AP, Salame G, Daugherty SL. Diagnostic Accuracy of Point-of-Care Lung Ultrasonography and Chest Radiography in Adults With Symptoms Suggestive of Acute Decompensated Heart Failure: A Systematic Review and Meta-analysis. JAMA Netw Open. 2019 Mar 1;2(3):e190703. doi: 10.1001/jamanetworkopen.2019.0703.

  PMID: 30874784 BACKGROUND

• van Eck van der Sluijs A, Bonenkamp AA, van Wallene VA, Hoekstra T, Lissenberg-Witte BI, Dekker FW, van Ittersum FJ, Verhaar MC, van Jaarsveld BC, Abrahams AC; DOMESTICO study group. Differences in hospitalisation between peritoneal dialysis and haemodialysis patients. Eur J Clin Invest. 2022 Jun;52(6):e13758. doi: 10.1111/eci.13758. Epub 2022 Feb 15.

  PMID: 35129213 BACKGROUND

MeSH Terms

Conditions

Edema

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Nupur Gupta

CONTACT

317-278-2868; nugupta@iu.edu

Srinath Yadlapalli

CONTACT

syadlap@iu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 17, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-08

Locations

US (1)