NCT06872645

Exploring Water-free Sodium Storage

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.

Detailed description

This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.

Conditions

• Peritoneal Dialysis, Heart Failure

Interventions

Type	Name	Description
DRUG	5% Dextrose/Water	Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days
DRUG	1.5% standard PD fluid	Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days

Timeline

• Start date: 2025-10-03
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-03-12
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States