Fluid OverloadNCT07178470
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)
A study testing point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS), Modified Medical Research Council (mMRC) Dyspnea scale and Physical Exam in people with Fluid Overload and POCUS, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Overload, POCUS, Lung Ultrasound
- What is being tested?
- point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS), Modified Medical Research Council (mMRC) Dyspnea scale and Physical Exam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Davita Home Dialysis of Indianapolis
Indianapolis, Indiana, 46260
About this study
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.
Read the detailed description
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.
- Conditions
- Fluid Overload, POCUS, Lung Ultrasound, Volume Status
- Being tested
- point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS), Modified Medical Research Council (mMRC) Dyspnea scale, Physical Exam
- Keywords
- pocus, fluid overload, lung ultrasound, volume status, modified Medical Research Council Dyspnea Scale, mMRC dyspnea scale
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS)Device
Also called Ultrasound device either Phillips or Butterfly
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
Modified Medical Research Council (mMRC) Dyspnea scaleOther
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 ExamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Dialysis Participants | Other | This study includes only one group all of whom get the same testing Receives: Device: point-of-care ultrasound (POCUS), specifically lung ultrasound (LUS); Other: Modified Medical Research Council (mMRC) Dyspnea scale; Other: Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the LUS and physical exam
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Agreement between the LUS and mMRC dyspnea scale
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Agreement between the physical exam and mMRc dyspnea scale.
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Secondary outcomes (6)
Correlation of mMRC dyspnea scale and blood pressure
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Correlation of mMRC dyspnea scale and weight
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Correlation of LUS and blood pressure
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Correlation of LUS and weight
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Correlation of physical exam and blood pressure
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Correlation of physical exam and weight
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.
Measured: Each participant will be involved in the study for 30-60 minutes, during which all interventions are performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start9 Jan 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Fluid OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nupur Gupta, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178470
- Sponsor's protocol ID
- 28387
- Status last verified
- Apr 2026
- First submitted
- 11 Sep 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35181839Mahler DA, Wells CK. Evaluation of clinical methods for rating dyspnea. Chest. 1988 Mar;93(3):580-6. doi: 10.1378/chest.93.3.580.
PubMed 3342669Alexandrou 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.
PubMed 35008093Maw 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.
PubMed 30874784van 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.
PubMed 35129213