Exploring Water-free Sodium Storage

Yale University10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Peritoneal Dialysis, Heart Failure

Interventions

5% Dextrose/WaterDRUG

Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days

1.5% standard PD fluidDRUG

Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ESRD Patients actively undergoing PD with a reliably functioning PD catheter * Systolic blood pressure \> 130 mmHg * Serum sodium \>135 mmol/L * daily urine output \< 400ml * stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution * PD vintage of at least 6 months * Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist Exclusion Criteria: * Poorly controlled diabetes with hemoglobin A1C\>9% * 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter * Anemia with hemoglobin \<8g/dL * Inability to give written informed consent or follow study protocol. * Urinary incontinence * Body weight \< 60kg * gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool. * use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).

Locations (1)

Yale University

New Haven, Connecticut, United States

RECRUITING

Outcomes

Primary Outcomes

Water free Na removal over the 5-day intervention

Water free Na removal will be calculated as \[Water Free Na= ((ΔTBW (L) \* serum Na (mmol/L)) - Na balance (mmol)\]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period

Time frame: Daily for 5 days

Central Contacts

Veena Rao, PhD

CONTACT

2037857917 veena.s.rao@yale.edu

Data from ClinicalTrials.gov

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