Understanding whether the body stores sodium without accompanying water

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Yale University
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Jeffrey Testani, MD — Yale University
• Study coordinator: Veena Rao, PhD
• Email: veena.s.rao@yale.edu
• Phone: 2037857917

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.