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Exploring Water-free Sodium Storage

NCT06872645 · Yale University
In plain English

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About this study
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.
Eligibility criteria
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 design
Enrollment target: 10 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-10-03
Estimated completion: 2028-06-30
Last updated: 2026-05-13
Interventions
Drug: 5% Dextrose/WaterDrug: 1.5% standard PD fluid
Primary outcomes
  • Water free Na removal over the 5-day intervention (Daily for 5 days)
Sponsor
Yale University · other
With: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Contacts & investigators
ContactVeena Rao, PhD · contact · veena.s.rao@yale.edu · 2037857917
InvestigatorJeffrey Testani, MD · principal_investigator, Yale University
All locations (1)
Yale UniversityRecruiting
New Haven, Connecticut, United States
Exploring Water-free Sodium Storage · TrialPath