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临床试验/NCT02742207
NCT02742207Unknown不适用

Evaluation of Renal Function and Fluid Balance of Patient Undergoing Electrical Cardioversion for Atrial Fibrillation

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2018年7月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Renal dysfunction

研究概览

简要总结

Atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. In a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(The incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. Helman Y,...Gilon D et al:Cardiology 2013;124(3);184-9.) Another complication previously described after cardioversion is pulmonary edema.

In this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. In addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. In order to assess hemodynamic changes the investigators will use a non-invasive FDA approved device called NICaS (Non-Invasive Cardiac System). This system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.

研究设计

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

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

  • All patients with new onset atrial fibrillation

排除标准

  • 未提供

结局指标

主要结局

Renal dysfunction

时间窗: Short term - One month

Creatinine Clearance less 25 percent.

次要结局

  • Mortality(One year)

研究者

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

Dan Gilon

Director, Non-Invasive Cardiology/Echocardiography

Hadassah Medical Organization

研究点 (1)

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