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Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery

2015年6月23日 更新者:Xijing Hospital

Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery

The purpose of this study is to evaluate the neuroprotective effect of electroacupuncture pretreatment in patients undergoing cardiac surgery as an preventive sequela in a randomized and controlled clinical trial. In addition, to investigate the role of inflammatory responses in the precess of the protection.

研究概览

详细说明

Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related cerebral injury is associated with worse patient morbidity and mortality after elective valve replacement surgery. Recently, Electroacupuncture (EA) pretreatment was proved to produced cerebral protective effects by mimicking ischemic preconditioning in animal models. However, the evidence that EA pretreatment can improve the clinical outcomes such as mortality and morbidity, is still lacking. The investigators perform a randomized controlled study to evaluate that EA pretreatment can improve the outcomes of cardiac surgery.

Purpose:

The purpose of this study is to examine if EA pretreatment can decrease the mortality and postoperative cerebrovascular complications in patients undergoing cardiac surgery. The effect will be assessed by mortality, scores of neurological defect, post operative cognitive dysfunction and stroke.

Methods:

Study patients will be randomized to cardiac surgery with EA pretreatment or conventional cardiac surgery in the Department of cardiovascular surgery, Xijing Hospital. EA pretreatment is performed at Baihui acupoint 30 min per day 5 consecutive days before the heart valve replacement surgery.Primary study outcome is cerebrovascular complications within 6 postoperative months. Secondary outcomes include the S-100B and NSE blood level measured during the first 72 hours of surgery follow-up, the several cytokines, including TNF-a, IL-8, IL-6, IL-10 and HMGB-1 blood level measured during the first 7 days of surgery follow-up, all cardiovascular haemodynamic parameters as measured by a pulmonary artery catheter, the length of intensive care unit (ICU) stay and length of postoperative hospital stay.

研究类型

介入性

注册 (预期的)

300

阶段

  • 不适用

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

    • Shaanxi
      • Xi'an、Shaanxi、中国、710032
        • Xijing Hospital

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

40年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

This study enrolls a group of 40-65years patients who have heart valve disease who need valve replacement.

Inclusion Criteria:

  • patients who have the indication for aortic or mitral valve replacement
  • patients would like to accept the follow-up and sign the informed consent
  • patients with heart function of NYHA I-III degree.

Exclusion Criteria:

  • pregnant or nursing women
  • comorbid with coronary artery disease
  • patients with heart function of NYHA IV degree
  • renal dysfunction with serum creatinine level>or=2mg/dl(177umol/L)
  • anticipated life span < 12 months
  • enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.

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

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
假比较器:控制
The same procedure as electroacupuncture except stimulation
有源比较器:Electroacupuncture
According to the theory of traditional Chinese medicine, Baihui(GV20) acupoint was chosen and the acupuncture points were identified according to traditional anatomical localization. Once insertion was made at the acupuncture point, the needle was stimulated electrically with the intensity of 0.8-1.9 mA and frequency of 5/30 Hz for 30 min per day using an Electronic Acupuncture Treatment Instrument for 5 consecutive days before the heart valve replacement surgery.
其他名称:
  • 针刺
  • preconditioning
  • electric stimulation

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Cerebrovascular complications and Score of neurological defect
大体时间:before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment
before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment

次要结果测量

结果测量
大体时间
The S-100B and NSE blood level
大体时间:before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up
before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up

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。

调查人员

  • 研究主任:Aideng Weng, Ph.D.、Xijing Hospital

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

2009年12月1日

初级完成 (实际的)

2010年9月1日

研究完成 (实际的)

2013年6月1日

研究注册日期

首次提交

2009年11月22日

首先提交符合 QC 标准的

2009年11月23日

首次发布 (估计)

2009年11月25日

研究记录更新

最后更新发布 (估计)

2015年6月25日

上次提交的符合 QC 标准的更新

2015年6月23日

最后验证

2009年11月1日

更多信息

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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