Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06408077

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

Led by University of Cologne · Updated on 2025-09-17

60

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hyponatremia is the most common electrolyte disorder of all and can be observed in more than 30% of all patients in hospitals. Osmotic homeostasis of body fluids is essential for survival of all living creatures. It is widely accepted that extra- and intracellular osmolalities are in equilibrium at all times and thus, changes in the extracellular osmolality will lead to either shrinkage or swelling of cells which can be detrimental. In severe cases, it can lead to swelling of the brain and death. Even in less dramatic scenarios, symptoms such as epileptic seizures, headaches, depression and dizziness exist, leading to an increased risk of fractures, hospital admissions and a considerable burden for affected patients. As short-term defense against osmotic stress, each individual cell is capable of actively externalizing or internalizing osmotically active solutes which restores normal or near-normal cell volume at the expense of an altered milieu interior. Obviously, there must be limitations to this strategy if intracellular integrity is meant to be kept stable. It has therefore been postulated that, apart from this cell-immanent mechanism, extracellular and intracellular electrolyte stores could assist in buffering osmotic imbalances. The Edelman formula states that extracellular sodium is determined by the total amount of exchangeable body sodium (the major extracellular cation) plus potassium (the major intracellular cation) divided by total body water. Several studies have shown, that it only partially explains the changes in patients outside the osmotic equilibrium. To better understand these physiological responses might not only promote the researcher's insight into the most basic cellular self-defense systems by measuring and comparing extra- and intracellular electrolyte concentrations with estimated changes in a patient that will be intravenously challenged with either water or sodium chloride 3%. The evolution over time of extra- and intracellular sodium and other electrolytes will be assessed quantitatively in patients with impaired renal function after water or sodium chloride (NaCl) administration.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years or older
  • Require renal replacement therapy due to surgical or non-surgical reasons
  • Stable hemodialysis treatment for at least 3 months
  • Urine output less than 100 ml 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
Not Eligible

You will not qualify if you...

  • Patients on peritoneal dialysis
  • Signs of volume expansion or contraction
  • Congestive heart failure NYHA class 2 or higher
  • Acute illness requiring hospital admission such as infection, heart failure, or liver cirrhosis
  • Uncontrolled arterial hypertension
  • Hemoglobin level 8 g/dL or lower
  • Alcohol abuse
  • Malnutrition
  • Persons employed or dependent on the investigators
  • Accommodation in an institution by judicial or administrative order

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Department II of Internal Medicine,University of Cologne

Cologne, Germany, 50937

Actively Recruiting

Loading map...

Research Team

V

Volker Burst, MD

CONTACT

S

Sadrija Cukoski, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here