RecruitingRecruiting
Exploring Water-free Sodium Storage
NCT06872645 · Yale University
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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