Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Early Phase 1

Completed

• Conditions: Potential Applications for Heart Failure; Volume Overload
• Interventions: Drug: Two-hour dwell with 10% dextrose in sterile water; Drug: Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose

• Registration Number: NCT03801226
• Lead Sponsor: Yale University

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 Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2018-12-12
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-11
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-31
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
10% dextrose in sterile water	Two-hour dwell with 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.
Dianeal Low-Calcium with 4.25% Dextrose	Two-hour dwell with 10% dextrose in sterile water	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.
10% dextrose in sterile water	Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose	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.
Dianeal Low-Calcium with 4.25% Dextrose	Two-hour dwell with 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States