Comparing symptom questions, physical exam, and handheld lung ultrasound to check fluid status in people on home dialysis
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)
Indiana University · NCT07178470
This will test whether handheld lung ultrasound (POCUS) detects extra fluid in the lungs more reliably than a one-question shortness-of-breath survey and the usual physical exam for adults on home dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT07178470 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with end-stage kidney disease who have been on peritoneal dialysis or home hemodialysis for at least three months. Participants provide consent for medical record review, have routine vitals and weight taken, complete a one-question modified Medical Research Council dyspnea scale, and receive the usual nephrology physical exam. The nephrologist performs their standard assessment blinded to the survey, and a trained operator then performs an eight-zone lung ultrasound (POCUS) to count B-lines; the visit lasts about 30–60 minutes and the ultrasound about 10–15 minutes. Data will be compared to measure agreement and discordance between symptoms, physical exam, and lung ultrasound findings in this home dialysis population.
Who should consider this trial
Good fit: Adults (age 18 or older) with end-stage kidney disease who have been receiving peritoneal dialysis or home hemodialysis for at least three months and can give informed consent are ideal candidates.
Not a fit: Patients who are pregnant, unable to consent, on urgent-start PD, or whose shortness of breath is clearly due to non-volume causes (for example pneumonia, pneumothorax, advanced COPD, or interstitial lung disease) are excluded and unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, using POCUS could help detect fluid overload earlier or more accurately in people on home dialysis, which may reduce preventable hospital visits.
How similar studies have performed: Lung ultrasound and POCUS have shown promise for detecting volume overload in in-center dialysis populations, but their specific performance and benefits in home dialysis patients are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Indianapolis, Indiana
- Davita Home Dialysis of Indianapolis — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Study coordinator: Nupur Gupta
- Email: nugupta@iu.edu
- Phone: 317-278-2868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fluid Overload, POCUS, Lung Ultrasound, Volume Status, pocus, fluid overload, lung ultrasound, volume status