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临床试验/NCT07255833
NCT07255833已完成不适用

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

University of Cologne1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
250
试验地点
1
主要终点
Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Comparison of quantitative (numeric) ECG features during and after resolution of hyponatremia.

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Volker Burst

Prof. Dr. med

University of Cologne

研究点 (1)

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