Clinical trial NCT05692726: Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
Official title: Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-hypervolemic Hyponatremia
Keywords: Electrolyte-free water clearance
hyponatremia
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with non-hypervolemic hyponatremia

Brief summary: To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia

Detailed description: Achieving recommended treatment targets in management of hyponatremia is challenging: plasma sodium must be increased effectively but, at the same time, overcorrection has to be prevented. Yet, predictors of change of sodium over time have not been delineated properly. It was found, that evidence hinting to the fact that sodium baseline itself is crucial with respect to sodium evolution.

The goal of this study is to gather prospective data in order to precisely delineate the role of initial sodium levels by correlating those to plasma sodium evolution and electrolyte free water evolution. It is aimed to decipher patterns of sodium evolution with respect to anthropometric data, such as body composition analyses and blood pressure and markers of innate regulation mechanisms of body volume like aldosterone and renin. In addition, apart from these clinical aspects, a better appreciation of the physiological responses to hyponatremia treatment in terms of water and electrolyte balances is undoubtedly necessary to improve understanding of the body's mechanisms involved in osmotic homeostasis and cell volume control. Since studies to date also lack consideration of the intracellular department, the aim is to close that gap.

Eligibility criteria: Inclusion Criteria:

* Adult patients ≥ 18 years
* Hypotonic hyponatremia

  * glucose-corrected plasma sodium \<130 mmol/l
  * serum osmolality \<280 mosmol/kg or lack of signs of non-hypotonic hyponatremia

Exclusion Criteria:

* Signs of extracellular volume expansion
* Patients with liver cirrhosis and severe liver damage AST/ALT\>3xULN, AP\>6xULN, Bilirubin ≥ 3mg/dl
* Patients with heart failure
* Patients on dialysis and/or patients with oliguric renal impairment and plasma creatinine ≥ 3mg/dl
* Patients after organ transplantation

Primary outcomes:
measure: Changes in Plasma Sodium
timeFrame: baseline, every day up to 30 days
measure: Changes in plasma osmolality
timeFrame: baseline, every day up to 30 days
measure: Changes in urine osmolality
timeFrame: baseline, every day up to 30 days
measure: Changes in urine volume
timeFrame: baseline, every day up to 30 days
Secondary outcomes:
measure: Changes in body weight
timeFrame: baseline, every day up to 30 days
measure: Changes in total body water
timeFrame: baseline, every day up to 30 days
measure: Changes in intracellular volume
timeFrame: baseline, every day up to 30 days
measure: Changes in extracellular volume
timeFrame: baseline, every day up to 30 days
measure: Changes in blood pressure
timeFrame: baseline, every day up to 30 days
measure: Changes in cell size
timeFrame: baseline, every day up to 30 days
measure: Changes in intracellular electrolyte levels
timeFrame: baseline, every day up to 30 days
measure: Changes in copeptin levels
timeFrame: baseline, every day up to 30 days
measure: Changes in renin levels
timeFrame: baseline, every day up to 30 days
measure: Changes in aldosterone levels
timeFrame: baseline, every day up to 30 days
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: University Hospital of Cologne
name: Volker Burst, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: