Managing sodium levels in patients with severe kidney disease
Regulation of Extracellular Sodium in End Stage Renal Disease Upon Volume and Electrolyte Challenges - a Prospective Trial.
NA · University of Cologne · NCT06408077
This study tests how giving water and salt to adults with severe kidney disease can help balance their sodium levels and improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne (other) |
| Locations | 1 site (Cologne) |
| Trial ID | NCT06408077 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require renal replacement therapy and have stable hemodialysis treatment.
Not a fit: Patients on peritoneal dialysis or those with acute illnesses or significant comorbidities may not benefit from this study.
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 performed: While there have been studies addressing electrolyte imbalances, this specific approach focusing on sodium regulation in end-stage renal disease is relatively novel.
Eligibility criteria
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 this trial is running
Cologne
- Department II of Internal Medicine,University of Cologne — Cologne, Germany (RECRUITING)
Study contacts
- Principal investigator: Volker Burst, MD — University Hospital of Cologne
- Study coordinator: Volker Burst, MD
- Email: volker.burst@uk-koeln.de
- Phone: +49 221 478 86285
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hyponatremia, hyponatremia, prospective trial, intracellular measurements, Water-Electrolyte Imbalance