Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)

Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)

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

Study Overview

• Status: Recruiting
• Conditions: Non-hypervolemic Hyponatremia
• Intervention / Treatment: Other: Patients

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Volker Burst, MD, Prof; Phone Number: +49 221-478-97222; Email: volker.burst@uk-koeln.de
• Study Contact Backup: Name: Sadrija Cukoski; Email: sadrija.cukoski@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University Hospital of Cologne
    • Contact: Sadrija Cukoski; Email: sadrija.cukoski@uk-koeln.de
    • Contact: Volker Burst, MD; Phone Number: +49(0)221 478 97222; Email: volker.burst@uk-koeln.de
    • Principal Investigator: Volker Burst, MD, Prof.
    • Sub-Investigator: Sadrija Cukoski

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with non-hypervolemic hyponatremia

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with non-hypervolemic hypotonic hyponatremia	Other: Patients; Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Plasma Sodium	Measurement of plasma sodium in blood samples	baseline, every day up to 30 days
Changes in plasma osmolality	Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment	baseline, every day up to 30 days
Changes in urine osmolality	Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality	baseline, every day up to 30 days
Changes in urine volume	Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume	baseline, every day up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in body weight	Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement	baseline, every day up to 30 days
Changes in total body water	Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement	baseline, every day up to 30 days
Changes in intracellular volume	Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement	baseline, every day up to 30 days
Changes in extracellular volume	Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement	baseline, every day up to 30 days
Changes in blood pressure	Measurement of blood pressure before, during and after hyponatremia treatment	baseline, every day up to 30 days
Changes in cell size	Determination of blood cell size via measurement of mean corpuscular volume	baseline, every day up to 30 days
Changes in intracellular electrolyte levels	Measurement of whole blood samples via ICP-mass spectrometry	baseline, every day up to 30 days
Changes in copeptin levels	Measurement of copeptin in blood samples	baseline, every day up to 30 days
Changes in renin levels	Measurement of renin in blood samples	baseline, every day up to 30 days
Changes in aldosterone levels	Measurement of aldosterone in blood samples	baseline, every day up to 30 days

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Volker Burst, MD, Prof., University Hospital of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: hyponatremia; Electrolyte-free water clearance
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Nutritional and Metabolic Diseases; Hyponatremia
• Other Study ID Numbers: V1.0-20220315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No