Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia

NCT07255833 | Completed

• 1 other identifier: Retro-EKG
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyponatremia

Keywords

hyponatremia; ECG; arrhythmias; cardiac; conduction

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline and up to 1 year

Secondary Outcomes (2)

• Comparison of qualitative ECG features during and after resolution of hyponatremia.

  at baseline and up to 1 year

• Detection of hyponatremia on the basis of ECG changes.

  at baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with profound hyponatremia presenting to the emergency department

You may qualify if:

• 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.
• lead-ECG on admission and a second ECG during inpatient care after resolution of profound hyponatremia.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Hyponatremia; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Volker Burst, MD, Prof

  University Hospital Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 1, 2025
• Study Start: June 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)