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NCT Number: NCT05692726

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Cologne

Cologne, 50937, Germany

Location status: Recruiting

Location contact

Sadrija Cukoski

CONTACT

[email protected]

Sadrija Cukoski

SUB_INVESTIGATOR

Volker Burst, MD

CONTACT

[email protected]

+49(0)221 478 97222

Volker Burst, MD, Prof.

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients

Other

Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge

Primary outcomes

  1. Changes in Plasma Sodium

    Time frame: baseline, every day up to 30 days

    Measurement of plasma sodium in blood samples

  2. Changes in plasma osmolality

    Time frame: baseline, every day up to 30 days

    Measurement of plasma osmolality for determination of electrolyte-free water clearance before, during and after hyponatremia treatment

  3. Changes in urine osmolality

    Time frame: baseline, every day up to 30 days

    Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine osmolality

  4. Changes in urine volume

    Time frame: baseline, every day up to 30 days

    Determination of electrolyte-free water clearance before, during and after hyponatremia treatment by measurement of urine volume

Secondary outcomes

  1. Changes in body weight

    Time frame: baseline, every day up to 30 days

    Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement

  2. Changes in total body water

    Time frame: baseline, every day up to 30 days

    Measurement of body water before, during and after hyponatremia treatment by bioimpedance measurement

  3. Changes in intracellular volume

    Time frame: baseline, every day up to 30 days

    Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement

  4. Changes in extracellular volume

    Time frame: baseline, every day up to 30 days

    Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement

  5. Changes in blood pressure

    Time frame: baseline, every day up to 30 days

    Measurement of blood pressure before, during and after hyponatremia treatment

  6. Changes in cell size

    Time frame: baseline, every day up to 30 days

    Determination of blood cell size via measurement of mean corpuscular volume

  7. Changes in intracellular electrolyte levels

    Time frame: baseline, every day up to 30 days

    Measurement of whole blood samples via ICP-mass spectrometry

  8. Changes in copeptin levels

    Time frame: baseline, every day up to 30 days

    Measurement of copeptin in blood samples

  9. Changes in renin levels

    Time frame: baseline, every day up to 30 days

    Measurement of renin in blood samples

  10. Changes in aldosterone levels

    Time frame: baseline, every day up to 30 days

    Measurement of aldosterone in blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Sadrija Cukoski

CONTACT

[email protected]

Volker Burst, MD, Prof

CONTACT

[email protected]

+49 221-478-97222

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Acronym: EvenT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2023
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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