Exploring Water-free Sodium Storage (NOS)

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.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Dialysis, Heart Failure
• Intervention / Treatment: Drug: 5% Dextrose/Water; Drug: 1.5% standard PD fluid

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veena Rao, PhD; Phone Number: 2037857917; Email: veena.s.rao@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale University
      • Principal Investigator: Jeffrey Testani, MD
      • Contact: Veena Rao, PhD; Phone Number: 203-785-7917; Email: veena.s.rao@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: 5% Dextrose/Water; Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Daily for 5 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total extracellular Na and osms	Change in total extracellular Na and osms will be calculated as [Change ECV Na = {ECV (L) * serum Na (mmol/L at baseline} - {ECV (L) * serum Na (mmol/L) after dwell). The same approach will be done for osms	Day 1 and day 5

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jeffrey Testani, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Carbohydrates; Inorganic Chemicals; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Oxides; Oxygen Compounds; Sugars; Hexoses; Monosaccharides; Water; Glucose
• Other Study ID Numbers: 2000039499; 1R01DK138155 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes