Exploring Water-free Sodium Storage
Recruiting · NCT06872645 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
1.5% standard PD fluid5% Dextrose/Water
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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).
Where it is running
1 location listed across 1 US state.
- Yale University - New Haven, Connecticut, United States