Potential Applications for Heart Failure, Volume Overload
Conditions
Keywords
Peritoneal dialysis
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.
Interventions
DRUGTwo-hour dwell with 10% dextrose in sterile water
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.
DRUGTwo-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose
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.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients actively undergoing peritoneal dialysis (PD) with a functioning PD catheter 2. PD vintage \< 3 years 3. As judged by treating nephrologist to be at or above optimal volume status (i.e., not dehydrated)
Exclusion criteria
1. Uncontrolled diabetes with frequent episodes of severe hyperglycemia 2. Systolic blood pressure \< 100 mmHg 3. Serum sodium \< 130 mEq/L 4. 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter 5. Anemia with hemoglobin \<8 g/dL 6. Serum bicarbinate \< 18 mEq/L 7. Anuric renal failure 8. Inability to give written informed consent or follow study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability measured by protocol discontinuation due to patient discomfort or adverse event | 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
| Measure | Time frame | Description |
|---|---|---|
| Comparison of total sodium removed compared to baseline | Two hours | This exploratory efficacy outcome will be addressed by comparing the quantity of sodium removed during the two-hour dwell between the two solutions |
Countries
United States
Outcome results
None listed