RightFit
RecruitingNot applicable

Exploring Water-free Sodium Storage

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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).

Study sites (1)

CT