Non-hypervolemic HyponatremiaEvenTNCT05692726
Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial
An observational study of Non-hypervolemic Hyponatremia, run by University of Cologne at 1 site in Germany.
Trial summary
To assess quantitatively the evolution over time of electrolyte-free water clearance and electrolyte mass balance in patients with non-hypervolemic hypotonic hyponatremia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-hypervolemic Hyponatremia
- What is being tested?
- Patients
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2022to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with non-hypervolemic hyponatremia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sadrija Cukoski contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, 50937
Volker Burst, MD, +49(0)221 478 97222, volker.burst@uk-koeln.de
Sadrija Cukoski, sadrija.cukoski@uk-koeln.de
About this study
Official title: 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
Read the 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.
- Conditions
- Non-hypervolemic Hyponatremia
- Being tested
- Patients
- Keywords
- Electrolyte-free water clearance, hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PatientsOther
Patients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with non-hypervolemic hypotonic hyponatremia Receives: Other: Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Plasma Sodium
Measurement of plasma sodium in blood samples
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, every day up to 30 days
Secondary outcomes (10)
Changes in body weight
Measurement of body weight before, during and after hyponatremia treatment by bioimpedance measurement
Measured: 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
Measured: baseline, every day up to 30 days
Changes in intracellular volume
Measurement of intracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
Measured: baseline, every day up to 30 days
Changes in extracellular volume
Measurement of extracellular volume before, during and after hyponatremia treatment by bioimpedance measurement
Measured: baseline, every day up to 30 days
Changes in blood pressure
Measurement of blood pressure before, during and after hyponatremia treatment
Measured: baseline, every day up to 30 days
Changes in cell size
Determination of blood cell size via measurement of mean corpuscular volume
Measured: baseline, every day up to 30 days
Changes in intracellular electrolyte levels
Measurement of whole blood samples via ICP-mass spectrometry
Measured: baseline, every day up to 30 days
Changes in copeptin levels
Measurement of copeptin in blood samples
Measured: baseline, every day up to 30 days
Changes in renin levels
Measurement of renin in blood samples
Measured: baseline, every day up to 30 days
Changes in aldosterone levels
Measurement of aldosterone in blood samples
Measured: baseline, every day up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start15 Oct 2022
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-hypervolemic HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Prof., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692726
- Sponsor's protocol ID
- V1.0-20220315
- Acronym
- EvenT
- Status last verified
- Sep 2025
- First submitted
- 11 Jan 2023
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Volume and Electrolyte Balance in Hyponatremia Treatment - a Prospective Observational Trial (EvenT)
- ClinicalTrials.gov ID
- NCT05692726
- Acronym / sponsor ID
- EvenT / V1.0-20220315
- Conditions
- Non-hypervolemic Hyponatremia
- Keywords
- Electrolyte-free water clearance, hyponatremia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: PatientsPatients with non-hypervolemic hypotonic hyponatremia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with non-hypervolemic hyponatremia
Key inclusion criteria (4 listed)
- Adult patients ≥ 18 years
- Hypotonic hyponatremia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PatientsPatients will get study-specific measurements within first 5 days of standard of care treatment of hyponatremia or until discharge | Other | Patients |
Primary outcome
Changes in Plasma Sodium
Time frame: baseline, every day up to 30 days
Measurement of plasma sodium in blood samples
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
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
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
10 secondary outcomes
Changes in body weight
Time frame: baseline, every day up to 30 days
Changes in total body water
Time frame: baseline, every day up to 30 days
Changes in intracellular volume
Time frame: baseline, every day up to 30 days
Changes in extracellular volume
Time frame: baseline, every day up to 30 days
Changes in blood pressure
Time frame: baseline, every day up to 30 days
Changes in cell size
Time frame: baseline, every day up to 30 days
Changes in intracellular electrolyte levels
Time frame: baseline, every day up to 30 days
Changes in copeptin levels
Time frame: baseline, every day up to 30 days
Changes in renin levels
Time frame: baseline, every day up to 30 days
Changes in aldosterone levels
Time frame: baseline, every day up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sadrija Cukoski contact
Volker Burst, MD, Prof. principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-hypervolemic Hyponatremia, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Volker Burst, MD, Prof (+49 221-478-97222, volker.burst@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Plasma Sodium (time frame: baseline, every day up to 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.