Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Yale University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter
- •PD vintage < 3 years
- •As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)
Exclusion Criteria
- •Uncontrolled diabetes with frequent episodes of severe hyperglycemia
- •Systolic blood pressure < 100 mmHg
- •Serum sodium < 130 mEq/L
- •1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
- •Anemia with hemoglobin <8 g/dL
- •Serum bicarbinate < 18 mEq/L
- •Anuric renal failure
- •Inability to give written informed consent or follow study protocol
Arms & Interventions
10% dextrose in sterile water
Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
Intervention: Two-hour dwell with 10% dextrose in sterile water (Drug)
10% dextrose in sterile water
Patients randomized to this arm will undergo a two-hour dwell with 10% dextrose in sterile water at their first visit and Dianeal Low-Calcium with 4.25% Dextrose at their second visit.
Intervention: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose (Drug)
Dianeal Low-Calcium with 4.25% Dextrose
Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
Intervention: Two-hour dwell with 10% dextrose in sterile water (Drug)
Dianeal Low-Calcium with 4.25% Dextrose
Patients randomized to this arm will undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first visit and 10% dextrose in sterile water at their second visit.
Intervention: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose (Drug)
Outcomes
Primary Outcomes
Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event
Time Frame: Two hours
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.
Secondary Outcomes
- Comparison of total sodium removed compared to baseline(Two hours)
Investigators
Jeffrey Testani
Associate Professor of Medicine
Yale University