Davita Home Dialysis of Indianapolis
Indianapolis, Indiana, 46260, United States
Location status: Recruiting
NCT Number: NCT07178470
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.
Interested in participating?
Request InfoAll sexes
Observational
Indianapolis, Indiana, 46260, United States
Location status: Recruiting
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Ultrasound device either Phillips or Butterfly
Time frame: 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
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Indiana University
Other
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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