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临床试验/NCT04151745
NCT04151745撤回不适用

Effect of Atrial Pacing on Right Ventricular Function After Cardiac Surgery

Medical Centre Leeuwarden0 个研究点开始时间: 2019年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
right ventricular ejection fraction

研究概览

简要总结

Temporary pacing with an external pacemaker after open heart surgery - besides preventing arrhythmias and AV-conduction disorders - is used to improve cardiac output. In theory, postoperative stunning temporarily limits stroke volume and SA-node dysfunction compromises an adequate compensatory rise in heartrate to ensure sufficient cardiac output. There is a lack of consensus regarding the use of this form of pacing. Protocols vary widely between hospitals. Moreover, the scientific base for this form of pacing mainly comprises studies dating back to the nineteen sixties and seventies. Major changes in (operating) techniques have taken place since then. Also, the role of the right ventricle in this context has not been studied specifically. The current study aims to investigate the effects of atrial pacing on right ventricular function specifically and hemodynamics in general, in today's postoperative setting. We hypothesize that a reduction in heart rate may lead to decreased right ventricular function.

详细描述

When a hemodynamically stable state is achieved, the external pacemaker will be switched off for 30 minutes. Hemodynamic parameters will be acquired directly prior to switching off, 15 respectively 30 minutes after switching off, and 15 minutes after switching back on. To gain insight in the natural course of stunning, this routine will be repeated the next morning. No additional hemodynamic interventions will be allowed in these periods.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • age 18 years or older
  • admitted to the ICU after onpump open heart surgery
  • Swan Ganz thermodilurion catheter in situ

排除标准

  • participation other trials
  • off pump cardiac surgery

结局指标

主要结局

right ventricular ejection fraction

时间窗: 30 minutes after procedure

difference in right ventricular function expressed in RVEF

次要结局

未报告次要终点

研究者

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Principal Investigator
主要研究者

E.C. Boerma

Principal Investigator

Medical Centre Leeuwarden

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