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

RecruitingNAAges 18 Years - anyAllUniversity of Cologne
NCT06408077 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Water administration
  • NaCl-Administration
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Where

1 site
Department II of Internal Medicine,University of Cologne
Cologne, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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