Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study

Conditions
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Potential Applications for Heart Failure, Volume Overload

Intervention / Treatment
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* Drug: Two-hour dwell with 10% dextrose in sterile water
* Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10% dextrose in sterile water<br>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. | Drug: Two-hour dwell with 10% dextrose in sterile water<br>* 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.<br>Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose<br>* 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.<br>|
| Active Comparator: Dianeal Low-Calcium with 4.25% Dextrose<br>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. | Drug: Two-hour dwell with 10% dextrose in sterile water<br>* 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.<br>Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Two hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal dialysis