HyponatremiaNCT07255833
Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia
An observational study of Hyponatremia, run by University of Cologne at 1 site in Germany.
Trial summary
The primary objective of this retrospective study is to determine the impact of hyponatremia on quantitative measurements and characteristics of the ECG. Secondary objectives comprise qualitative ECG features during hyponatremia, such as lead type, rhythm, etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2022to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with profound hyponatremia presenting to the emergency department
Who may be able to join
- Adult patients ≥18 years of the Emergency Department of the University Hospital of Cologne/Germany
- Plasma sodium ≤125 mmol/L in the admission blood sample and ≥ 130 mEq/L in a subsequent sample obtained during inpatient care.
- 12-lead-ECG on admission and a second ECG during inpatient care after resolution of profound hyponatremia.
Who cannot join
- Lack of follow-up sodium analyses within the first 24 hours after admission
- initial blood glucose >300 mg/dL
- Moderate or severe hypokalemia (potassium level < 3 mmol/L)
- Moderate or severe hyperkalemia (potassium level > 6 mmol/L)
- Pacemaker dependency with ventricular pacing
- Relevant structural heart disease
Show all 13Show fewer
- Severe ischemic cardiomyopathy with an EF < 35%
- Untreated severe aortic valve stenosis
- Dilated cardiomyopathy (DCM)
- Hypertrophic cardiomyopathy (HCM)
- Arrhythmogenic right ventricular cardiomyopathy (ARVC)
- Infiltrative cardiomyopathy
- Ion channel disease
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this retrospective study is to determine the impact of hyponatremia on quantitative measurements and characteristics of the ECG. Secondary objectives comprise qualitative ECG features during hyponatremia, such as lead type, rhythm, etc.
Read the detailed description
Hyponatremia is the most common electrolyte disorder in hospitalized patients. It is associated with high morbidity and mortality. Acute profound hyponatremia is defined by a drop in sodium level to < 125 mEq/L within ≤ 48 h. As the cation with the highest extracellular concentration, sodium is the main determinant of serum osmolality. Thus, profound hyponatremia can lead to hypoosmolality of the serum (< 275 mosmol/kg) and a resulting osmotic gradient to a variably pronounced cerebral edema with neurological and/or psychiatric symptoms such as confusion, nausea, psychosis, vigilance disorder up to coma or seizures.
While the effects of hyponatremia on the central nervous system (CNS) are well characterized, its effects on cardiac function, particularly excitation and conduction system, are poorly understood. Thus, it is unclear whether osmotically induced swelling of human cardiomyocytes is a possible pathophysiological mechanism for cardiac dysfunction. In animal studies with isolated ventricular cardiomyocytes from rabbit hearts, significant swelling of cardiomyocytes was shown under osmotic stress in both ischemic preconditioned and non-preconditioned cells. In another experimental study, Yanagi et al. systematically investigated the effects of decreasing extracellular sodium concentration on the mechanical and electrophysiological properties of pig hearts in the Langendorff perfusion model. Electrocardiographic changes in the PQ interval and QT duration were demonstrated with decreasing sodium concentration as an expression of impaired atrioventricular and intraventricular conduction.
In contrast, there are no clinical cohort studies in which the frequency and prognostic relevance of electrocardiographic changes and arrhythmias in profound hyponatremia have been investigated. The majority of publications comprise case reports and small case series describing variable and mostly reversible electrocardiographic changes and arrhythmias associated with profound hyponatremia.
The electrocardiogram (ECG) as a primary basic diagnostic tool plays a central role in cardiology and emergency medicine in particular for clarifying chest pain, shortness of breath, palpitations and dizziness/syncope. In addition, it can also provide indications of pathologies outside the cardiovascular system such as intoxication or electrolyte disorders or be used to monitor drug therapy.
The extent to which the ECG can be used in the diagnosis and risk stratification of profound hyponatremia cannot be answered today, but the aforementioned case reports suggest that hyponatremia might have an influence on the electrophysiological processes of the heart and thus the ECG.
The primary objective of this retrospective study is to determine the impact of hyponatremia on quantitative measurements and characteristics of the ECG. Secondary objectives comprise qualitative ECG features during hyponatremia, such as lead type, rhythm, etc. All ECG are evaluated by cardiologists as well as an automated AI application during and after resolution of hyponatremia.
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, ECG, arrhythmias, cardiac, conduction
- Medical subject headings
- Hyponatremia, Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia.
The primary aim is to determine the influence of hyponatremia on numeric ECG features of cardiac conduction (i.e., heart rate [beats per minute, bpm], RR interval [milliseconds, ms], PQ interval [ms], QRS duration [ms], (corrected) QT duration [ms], T-Wave [millimeters, mm], changes in ST segment, including ST elevations [mm] (STEMI mimics), ST depressions [mm]) in a large cohort of patients in the emergency department (ED). It is also to determine in a before-after comparison whether these features changed after correction of profound hyponatremia.
Measured: at baseline and up to 1 year
Secondary outcomes (2)
Comparison of qualitative ECG features during and after resolution of hyponatremia.
Secondary outcome measures comprise qualitative (non-numeric) characteristics of the ECG waveform, such as ECG lead type, rhythm, changes in ST segment, including ST elevations (STEMI mimics), ST depressions, T wave inversions, block patterns, conduction disturbances, Brugada-typical changes, etc. in the same ED cohort during hyponatremia. A before-after comparison was performed to assess whether these features changed after correction of profound hyponatremia.
Measured: at baseline and up to 1 year
Detection of hyponatremia on the basis of ECG changes.
To determine the sensitivity and specificity of the ECG for profound hyponatremia.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Jun 2022
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 250 participants (actual)
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
- NCT07255833
- Sponsor's protocol ID
- Retro-EKG
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data base will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia
- ClinicalTrials.gov ID
- NCT07255833
- Acronym / sponsor ID
- Retro-EKG
- Conditions
- Hyponatremia
- Keywords
- hyponatremia, ECG, arrhythmias, cardiac, conduction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Dec 2025 (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.
The primary objective of this retrospective study is to determine the impact of hyponatremia on quantitative measurements and characteristics of the ECG. Secondary objectives comprise qualitative ECG features during hyponatremia, such as lead type, rhythm, etc.
Detailed description
Hyponatremia is the most common electrolyte disorder in hospitalized patients. It is associated with high morbidity and mortality. Acute profound hyponatremia is defined by a drop in sodium level to < 125 mEq/L within ≤ 48 h. As the cation with the highest extracellular concentration, sodium is the main determinant of serum osmolality. Thus, profound hyponatremia can lead to hypoosmolality of the serum (< 275 mosmol/kg) and a resulting osmotic gradient to a variably pronounced cerebral edema with neurological and/or psychiatric symptoms such as confusion, nausea, psychosis, vigilance disorder up to coma or seizures.
While the effects of hyponatremia on the central nervous system (CNS) are well characterized, its effects on cardiac function, particularly excitation and conduction system, are poorly understood. Thus, it is unclear whether osmotically induced swelling of human cardiomyocytes is a possible pathophysiological mechanism for cardiac dysfunction. In animal studies with isolated ventricular cardiomyocytes from rabbit hearts, significant swelling of cardiomyocytes was shown under osmotic stress in both ischemic preconditioned and non-preconditioned cells. In another experimental study, Yanagi et al. systematically investigated the effects of decreasing extracellular sodium concentration on the mechanical and electrophysiological properties of pig hearts in the Langendorff perfusion model. Electrocardiographic changes in the PQ interval and QT duration were demonstrated with decreasing sodium concentration as an expression of impaired atrioventricular and intraventricular conduction.
In contrast, there are no clinical cohort studies in which the frequency and prognostic relevance of electrocardiographic changes and arrhythmias in profound hyponatremia have been investigated. The majority of publications comprise case reports and small case series describing variable and mostly reversible electrocardiographic changes and arrhythmias associated with profound hyponatremia.
The electrocardiogram (ECG) as a primary basic diagnostic tool plays a central role in cardiology and emergency medicine in particular for clarifying chest pain, shortness of breath, palpitations and dizziness/syncope. In addition, it can also provide indications of pathologies outside the cardiovascular system such as intoxication or electrolyte disorders or be used to monitor drug therapy.
The extent to which the ECG can be used in the diagnosis and risk stratification of profound hyponatremia cannot be answered today, but the aforementioned case reports suggest that hyponatremia might have an influence on the electrophysiological processes of the heart and thus the ECG.
The primary objective of this retrospective study is to determine the impact of hyponatremia on quantitative measurements and characteristics of the ECG. Secondary objectives comprise qualitative ECG features during hyponatremia, such as lead type, rhythm, etc. All ECG are evaluated by cardiologists as well as an automated AI application during and after resolution of hyponatremia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with profound hyponatremia presenting to the emergency department
Key inclusion criteria (3 listed)
- Adult patients ≥18 years of the Emergency Department of the University Hospital of Cologne/Germany
- Plasma sodium ≤125 mmol/L in the admission blood sample and ≥ 130 mEq/L in a subsequent sample obtained during inpatient care.
- 12-lead-ECG on admission and a second ECG during inpatient care after resolution of profound hyponatremia.
Key exclusion criteria (13 listed)
- Lack of follow-up sodium analyses within the first 24 hours after admission
- initial blood glucose >300 mg/dL
- Moderate or severe hypokalemia (potassium level < 3 mmol/L)
- Moderate or severe hyperkalemia (potassium level > 6 mmol/L)
- Pacemaker dependency with ventricular pacing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia.
Time frame: at baseline and up to 1 year
The primary aim is to determine the influence of hyponatremia on numeric ECG features of cardiac conduction (i.e., heart rate [beats per minute, bpm], RR interval [milliseconds, ms], PQ interval [ms], QRS duration [ms], (corrected) QT duration [ms], T-Wave [millimeters, mm], changes in ST segment, including ST elevations [mm] (STEMI mimics), ST depressions [mm]) in a large cohort of patients in the emergency department (ED). It is also to determine in a before-after comparison whether these features changed after correction of profound hyponatremia.
2 secondary outcomes
Comparison of qualitative ECG features during and after resolution of hyponatremia.
Time frame: at baseline and up to 1 year
Detection of hyponatremia on the basis of ECG changes.
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: Yes. Data base will be shared upon request
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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. This study is not recruiting at the moment.
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 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 3 inclusion and 13 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: finished, as of the sponsor's last update on 1 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia. (time frame: at baseline and up to 1 year). 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 1 Dec 2025.