Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Managing sodium levels in patients with severe kidney disease

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

Run by University of Cologne · NCT06408077 · Data updated 2026-11-12

This study tests how giving water and salt to adults with severe kidney disease can help balance their sodium levels and improve their health.

More Hyponatremia trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment60 (estimated)
SponsorUniversity of Cologne
Academic / other
Locations1 site (Cologne)
StatusRecruiting
StartedJuly 1, 2023
Main results expectedMay 31, 2026
Study endsMay 31, 2026
Registry record updatedSeptember 17, 2025
Trial IDNCT06408077 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who require renal replacement therapy and have stable hemodialysis treatment.

Probably not a fit

Patients on peritoneal dialysis or those with acute illnesses or significant comorbidities may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the regulation of extracellular sodium levels in patients with end-stage renal disease who are undergoing volume and electrolyte challenges. It focuses on the effects of water and sodium chloride administration on patients with hyponatremia, a common electrolyte disorder. By monitoring intracellular measurements, the study aims to understand how these interventions can restore osmotic balance and improve patient outcomes. The research targets adult patients requiring renal replacement therapy and aims to provide insights into effective management strategies for electrolyte imbalances.

Why it matters

Potential benefit: If successful, this study could lead to improved management of hyponatremia in patients with end-stage renal disease, potentially reducing complications and enhancing quality of life.

How similar studies have gone: While there have been studies addressing electrolyte imbalances, this specific approach focusing on sodium regulation in end-stage renal disease is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Department II of Internal Medicine,University of Cologne
    Cologne, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.