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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Exploring Water-free Sodium Storage
At a glance
Conditions
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.
Study leadership
- Jeffrey Testani, MD · PRINCIPAL_INVESTIGATOR · Yale University
Who to contact
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Inclusion
Exclusion
What this trial measures
- 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