NCT03801226

Zero Sodium Peritoneal Dialysate Protocol Pilot Study

Zero Sodium Peritoneal Dialysate Protocol in Human Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Potential Applications for Heart Failure
• Volume Overload

Interventions

Type	Name	Description
DRUG	Two-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.
DRUG	Two-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.

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-05-01
• Completion: 2019-05-31
• First posted: 2019-01-11
• Last updated: 2019-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study