Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia (NCT07255833) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Analysis of ECG Changes and Arrhythmias in Patients With Profound Hyponatremia
Germany250 participantsStarted 2022-06-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia.