Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT07255833
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07255833
Study Brief:
Protocol Section:
NCT07255833