Exploring Water-free Sodium Storage in Peritoneal Dialysis and Heart Failure

This study is looking into how the body stores and releases sodium (salt) without water, especially in people with peritoneal dialysis (PD) and heart failure. You would receive either 5% Dextrose/Water or 1.5% standard PD fluid for five days. After a six-week break, you would then receive the other treatment for another five days. Researchers want to see if a significant amount of sodium can be stored and released in the body, and where this happens. To join, you must be an adult (18+) with end-stage renal disease (ESRD) on PD, have stable blood pressure (above 130 mmHg systolic), and a serum sodium level above 135 mmol/L. The study aims to measure how much water-free sodium is removed over the five-day treatment periods. The current recruitment status is unclear, and the study plans to enroll 10 participants.

Study design
This is a randomized, blinded crossover study where participants will receive two different treatments over time. The study plans to enroll 10 participants.
What's involved
You would receive one treatment for 5 days, followed by a 6-week break, and then the alternate treatment for another 5 days. Water-free sodium removal will be measured daily during the treatment periods.
Compensation
Not stated in the trial record.
Follow-up
Water-free sodium removal is measured daily for 5 days during each treatment period. There is a 6-week washout period between treatments.

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NCT06872645

Exploring Water-free Sodium Storage

Recruiting
NAAges 18+InterventionalBasic science
Yale University
~10 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:5% Dextrose/Water1.5% standard PD fluid

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Water free Na removal over the 5-day intervention
Measured over Daily for 5 days
Peritoneal Dialysis, Heart Failure

NCT06872645

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale University

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jeffrey Testani, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

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).
  • Water free Na removal over the 5-day interventionDaily for 5 days

    Water free Na removal will be calculated as \[Water Free Na= ((ΔTBW (L) \* serum Na (mmol/L)) - Na balance (mmol)\]. This will be compared between 5% dextrose Na removal period and 1.5% dextrose standard PD neutral Na balance period