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Search / Trial NCT06872645

Exploring Water-free Sodium Storage

Launched by YALE UNIVERSITY · Mar 6, 2025

Trial Information

Current as of April 30, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how the body stores and releases sodium (a type of salt) without water, particularly in patients who are undergoing peritoneal dialysis (a treatment for kidney failure) and have heart failure. The researchers want to find out if this process happens quickly, how much sodium is involved, and where it occurs in the body. This information could help improve treatment strategies for patients with these conditions.

To participate in the trial, you need to be an adult aged 65 to 74 who is currently receiving peritoneal dialysis and has a stable treatment plan. You should have normal blood pressure and sodium levels, and your kidney function should be stable. However, individuals with certain health issues, such as poorly controlled diabetes or recent infections, may not be eligible. The trial is not yet recruiting participants, but if you join later, you can expect to follow specific study guidelines and provide informed consent. This research could lead to better understanding and management of sodium levels, which is important for your health.

Gender

ALL

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).

About Yale University

Yale University, a prestigious Ivy League institution located in New Haven, Connecticut, is renowned for its commitment to advancing medical research and clinical innovation. With a rich history of academic excellence and a robust infrastructure for scientific inquiry, Yale serves as a leading sponsor for clinical trials aimed at improving patient care and developing new therapeutic approaches. The university's multidisciplinary teams of researchers and clinicians collaborate to conduct rigorous and ethical studies, leveraging cutting-edge technologies and methodologies to address critical health challenges. Through its dedication to fostering an environment of inquiry and discovery, Yale University plays a pivotal role in translating research findings into clinical practice, ultimately enhancing health outcomes for diverse populations.

Locations

Patients applied

0 patients applied

Trial Officials

Jeffrey Testani, MD

Principal Investigator

Yale University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported