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NCT06408077Recruiting

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

Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges - a Prospective Trial.

Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
3 May 2024
Start date
Jul 2023
Primary completion date
May 2026
Lead sponsor
University of Cologne
NCT number
NCT06408077

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From Jul 2023 to the primary completion date, May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Congestive heart failure (NYHA ≥2)
  • acute illness (infection, congestive heart failure, liver cirrhosis, etc.) requiring hospital admission
  • Uncontrolled arterial hypertension

Lab values

  • Hemoglobin ≤8g/dL

Other

  • Peritoneal dialysis patients
  • Signs of volume expansion or contraction
  • Alcohol abuse
  • Malnutrition
  • Persons, who are in a dependency/employment relationship with the investigators
  • Accommodation in an institution by judicial or administrative order

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department II of Internal Medicine,University of Cologne
Coordinator of this site? Confirm its status
CologneGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.