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Stroke Volume Analysis During Aortic Valve Replacement Trial (standart)

2014年8月7日 更新者：Michael Sander、Charite University, Berlin, Germany
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.

研究概览

地位

未知

条件

研究类型

观察性的

注册 (预期的)

68

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Berlin、德国、10117
        • 招聘中
        • Charité Universitätsmedizin Berin
        • 副研究员：
          • Felix Balzer, MD
        • 接触：
        • 副研究员：
          • Sascha Treskatsch, MD
        • 副研究员：
          • Marit Habicher, MD
        • 副研究员：
          • Viktor Mezger, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Cardiac surgery at a university hospital

描述

Inclusion Criteria:

  • scheduled transcatheter aortic valve implantation
  • signed patient consent form
  • aged 18 or older by time of surgery
  • no participation in other clinical trials

Exclusion Criteria:

  • pregnant or breast-feeding women
  • emergency surgery

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Hemodynamic optimisation
No hemodynamic optimisation

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
大体时间：Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
大体时间：Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

次要结果测量

结果测量
大体时间
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
大体时间：After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
大体时间：Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
大体时间：Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
大体时间：After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

其他结果措施

结果测量
大体时间
oxygen delivery (ml)
大体时间：Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
image quality of echocardiography
大体时间：Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Length of stay on ICU
大体时间：participants will be followed for the duration of hospital stay, an expected average of 2 weeks
participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Cumulative rate of infections
大体时间：after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of delirium after surgery
大体时间：after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
dosage of inotropic medication (mg/d)
大体时间：after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
length of hospital stay
大体时间：after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
incidence of stroke
大体时间：after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Charite University, Berlin, Germany

调查人员

  • 首席研究员：Michael Sander, MD、Charite University, Berlin, Germany

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年5月1日

初级完成 (预期的)

2015年5月1日

研究注册日期

首次提交

2014年5月20日

首先提交符合 QC 标准的

2014年6月2日

首次发布 (估计)

2014年6月5日

研究记录更新

最后更新发布 (估计)

2014年8月8日

上次提交的符合 QC 标准的更新

2014年8月7日

最后验证

2014年8月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • EA1/060/13

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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