RecruitingNot ApplicableNCT06872645
Exploring Water-free Sodium Storage
Sponsor
Yale University
Enrollment
10 participants
Start Date
Oct 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria8
- Poorly controlled diabetes with hemoglobin A1C\>9%
- 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).
Interventions
DRUG5% Dextrose/Water
Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days
DRUG1.5% standard PD fluid
Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06872645