Understanding whether the body stores sodium without accompanying water

Exploring Water-free Sodium Storage

Test if switching peritoneal dialysis fluid to a water-only dextrose solution versus standard dialysis fluid causes measurable water-free sodium storage or release in people on peritoneal dialysis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT06872645 on ClinicalTrials.gov

What this trial studies

This is an inpatient, randomized, blinded crossover trial in people receiving peritoneal dialysis that compares 5% dextrose (water-only) dialysis fluid with standard 1.5% Dianeal PD fluid over two five-day treatment periods separated by a six-week washout. Participants will undergo ultra-rigorous balance measurements and tissue sodium measurements to determine whether significant mobilizable sodium is stored independently of extracellular water and to explore its likely location. The protocol controls fluid and sodium exposure closely while blinded randomization reduces bias. Results will quantify the amount and direction of sodium shifts between treatments and evaluate whether those shifts are physiologically meaningful.

Who should consider this trial

Good fit: Adults with end-stage renal disease actively on peritoneal dialysis who are euvolemic at their dry weight, have systolic blood pressure over 130 mmHg, serum sodium above 135 mmol/L, daily urine output under 400 mL, stable PD prescription for at least 2 months, PD vintage of at least 6 months, and body weight at least 60 kg are the intended participants.

Not a fit: Patients with uncontrolled diabetes (A1C >9%), recent or active peritonitis or catheter infection, anemia with hemoglobin <8 g/dL, urinary incontinence, significant gastrointestinal sodium losses, recent amiodarone use, inability to consent or follow protocol, or body weight under 60 kg are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could improve understanding of sodium handling and lead to new ways to manage salt and fluid balance in patients on peritoneal dialysis and related heart-failure care.

How similar studies have performed: This is an exploratory and relatively novel human investigation; prior human data on substantial water-free sodium storage are limited and not definitive.

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).

Where this trial is running

New Haven, Connecticut

• Yale University — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Principal investigator: Jeffrey Testani, MD — Yale University
• Study coordinator: Veena Rao, PhD

Conditions Peritoneal Dialysis, Heart Failure