An observational study in Kidney Failure, Chronic, Renal Failure Chronic and Hemodialysis, sponsored by ImpediMed Limited. Status unknown at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by ImpediMed Limited · Observational
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis.
This observational study will evaluate bioimpedance spectroscopy (BIS) measurements from patients undergoing hemodialysis. If changes in BIS parameters correlate with changes in fluid volume and patient symptoms, BIS may help provide a non-invasive way to estimate the amount of fluid to dialyze during a hemodialysis session. Data from this study may be used to inform the design of a future interventional trial of BIS use in hemodialysis patients.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 70 is below the median of 120 across 441 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →ImpediMed Limited is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Adults (aged 18+ years) with end-stage renal disease, are known to a study investigator, and undergo hemodialysis 3-times per week at an outpatient dialysis unit.
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Exclusion Criteria:
Up to 50 patients on hemodialysis \>6 months, with stable target/dry weight, and have not been hospitalized recently
Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device
Up to 20 patients who have been on hemodialysis \<6 months, or have unintended weight loss/gain, or have recently been hospitalized
Device: Bioimpedance spectroscopy (BIS) measurement, SOZO device
All patients enrolled in this study will undergo BIS measurement before and after 12 hemodialysis sessions (pre-dialysis and post-dialysis BIS measurements for each session). Measurements are not provided to treating physicians and are not used to guide clinical decisions; i.e., BIS measurements are collected for observational purposes only.
BIS correlation with amount of fluid dialyzed
BIS-measured fluid change (volume) will be analyzed for correlation with the volume of fluid removed during hemodialysis as documented on dialysis treatment records.
Time frame: 12 hemodialysis sessions (over 4 to 6 weeks)
Plan to share: No
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This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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ImpediMed Limited