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Search / Trial NCT06408077

Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges

Launched by UNIVERSITY OF COLOGNE · May 7, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hyponatremia Prospective Trial Intracellular Measurements Water Electrolyte Imbalance

ClinConnect Summary

This clinical trial is studying a condition called hyponatremia, which is when there is not enough sodium in the blood. Sodium is an important electrolyte that helps maintain the balance of fluids in our bodies. This trial aims to understand how sodium levels change in patients with kidney problems when they are given extra fluids or sodium. By observing these changes, researchers hope to learn more about how our cells manage fluid balance, which is crucial for preventing serious health issues like brain swelling, seizures, or other symptoms that can affect daily life.

To participate in this study, candidates must be adults over 18 years old who require dialysis because of kidney issues. They should have been on stable dialysis for at least three months and have specific blood sodium and potassium levels. Participants can expect to have their blood and electrolyte levels monitored after receiving either water or a sodium solution. This research could provide valuable insights into how to better manage sodium levels in patients with kidney disease, ultimately improving their health outcomes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patients ≥18 years
  • Requirement of renal replacement therapy due to surgical (i.e., nephrectomy) or non-surgical (chronic kidney disease) reason
  • Stable hemodialysis treatment for at least 3 months
  • Urine output \<100ml in 24 hours
  • Glucose-corrected plasma sodium between 135 mmol/l and 145 mmol/l
  • Plasma potassium between 3.5 mmol/l and 5 mmol/l
  • Written informed consent
  • Exclusion Criteria:
  • Peritoneal dialysis patients
  • Signs of volume expansion or contraction
  • Congestive heart failure (NYHA ≥2)
  • acute illness (infection, congestive heart failure, liver cirrhosis, etc.) requiring hospital admission
  • Uncontrolled arterial hypertension
  • Hemoglobin ≤8g/dL
  • Alcohol abuse
  • Malnutrition
  • Persons, who are in a dependency/employment relationship with the investigators
  • Accommodation in an institution by judicial or administrative order

About University Of Cologne

The University of Cologne, a prestigious institution located in Germany, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, the university leverages its extensive academic resources and expertise to design and conduct innovative studies aimed at improving patient care and health outcomes. With a focus on collaboration across various disciplines, the University of Cologne emphasizes rigorous scientific methodologies and ethical standards in its clinical research initiatives, contributing significantly to the global medical community and fostering the development of new therapeutic strategies.

Locations

Cologne, , Germany

Patients applied

0 patients applied

Trial Officials

Volker Burst, MD

Principal Investigator

University Hospital of Cologne

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported