Yale University
New Haven, Connecticut, 06510, United States
Location status: Recruiting
NCT Number: NCT06872645
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06510, United States
Location status: Recruiting
This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will be randomized to undergo up to two-hour dwell with 5% dextrose in sterile water for 5 days
Patients will be randomized to undergo up to two-hour dwell with 1.5% standard PD fluid for 5 days
Time frame: Daily 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
Time frame: Day 1 and day 5
Change in total extracellular Na and osms will be calculated as [Change ECV Na = {ECV (L) * serum Na (mmol/L at baseline} - {ECV (L) * serum Na (mmol/L) after dwell).
The same approach will be done for osms
Contact information is provided by the study sponsor or research team.
Yale University
Other
Acronym: NOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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