Exploring Water-free Sodium Storage

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06872645
Status
Recruiting

Conditions

  • Peritoneal Dialysis, Heart Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 5% dextrose peritoneal dialysis, 2-hour dwell
    Individuals will receive up to 2 liters of 5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days
  • Active Comparator: 1.5% dextrose peritoneal dialysis, 2-hour dwell
    Individuals will receive up to 2 liters of 1.5% dextrose for peritoneal dialysis during up to a 2-hour dwell for 5 days

Primary Outcome Measure

Water free Na removal over the 5-day intervention [ Time Frame: Daily for 5 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Veena Rao, PhD
203-785-7917
Jeffrey Testani, MD (PRINCIPAL_INVESTIGATOR)

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