The following pilot study will be undertaken to determine the effects of use of a zero-sodium peritoneal dialysate solution (10% dextrose in sterile water) on sodium removal as compared to a standard peritoneal dialysis solution.
While heart failure (HF) is generally regarded as the inability of the heart to pump sufficient blood, on a population level, volume overload is the primary driver of morbidity and hospitalization. The signs and symptoms of volume overload are driven by water accumulation, which is initially driven by sodium retention. This overall goal of this study is to investigate the ability to remove sodium through use of a zero-sodium solution in peritoneal dialysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.
Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.
Yale University
New Haven, Connecticut, United States
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Protocol discontinuation will be defined by premature draining of the 10% dextrose peritoneal solution (or 4.25% standard PD solution) prior to the planned two hour drain.
Time frame: Two hours
Comparison of total sodium removed compared to baseline
This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions
Time frame: Two hours
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