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

NCT06408077 | Recruiting

• 1 other identifier: V1.2_2023-06-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hyponatremia

Keywords

hyponatremia; prospective trial; intracellular measurements; Water-Electrolyte Imbalance

Outcome Measures

Primary Outcomes (1)

• acute changes of extracellular osmolality

  The primary aim is to compare the actual acute change of extracellular sodium with the estimated change of extracellular sodium in response to an intravenous challenge with either water or sodium. Precise evaluation of the validity of the concept of Edelman in acute changes of extracellular osmolality

  300 minutes after infusion

Secondary Outcomes (4)

• change of extracellular electrolyte concentrations

  300 minutes after infusion

• change of intracellular electrolyte concentrations

  300 minutes after infusion

• change of osmolality

  300 minutes after infusion

• change of cell volume

  300 minutes after infusion

Study Arms (2)

Water-Group

EXPERIMENTAL

Intravenous administration of water (Aqua ad injectabilia) until a decrease of plasma sodium of 5 to 8 mmol/l has been achieved

Other: Water administration

NaCl-Group

EXPERIMENTAL

Intravenous administration of NaCl 3% until an increase of plasma sodium of 5 to 8 mmol/l has been achieved

Other: NaCl-Administration

Interventions

Water administration OTHER

Intravenous administration of water (Aqua ad injectabilia) until a decrease of plasma sodium of 5 to 8 mmol/l has been achieved

Water-Group

NaCl-Administration OTHER

Intravenous administration of NaCl 3% until an increase of plasma sodium of 5 to 8 mmol/l has been achieved

NaCl-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

Department II of Internal Medicine,University of Cologne

Cologne, 50937, Germany

RECRUITING

MeSH Terms

Conditions

Hyponatremia; Water-Electrolyte Imbalance

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Volker Burst, MD

  University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Volker Burst, MD

CONTACT

+49 221 478 86285; volker.burst@uk-koeln.de

Sadrija Cukoski, MD

CONTACT

sadrija.cukoski@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 9, 2024
• Study Start: July 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

DE (1)