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Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Fourth Military Medical University
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01020266
First received: November 22, 2009
Last updated: November 23, 2009
Last verified: November 2009

November 22, 2009
November 23, 2009
December 2009
September 2010   (final data collection date for primary outcome measure)
Cerebrovascular complications and Score of neurological defect [ Time Frame: before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01020266 on ClinicalTrials.gov Archive Site
The S-100B and NSE blood level [ Time Frame: before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • Stroke
  • Brain Injuries
  • Procedure: non electroacupuncture stimulation
    The same procedure as electroacupuncture except stimulation
  • Procedure: Electroacupuncture pretreatment
    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.
    Other Names:
    • Acupuncture
    • preconditioning
    • electric stimulation
  • Active Comparator: Electroacupuncture
    Intervention: Procedure: Electroacupuncture pretreatment
  • Sham Comparator: Control
    Intervention: Procedure: non electroacupuncture stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
June 2011
September 2010   (final data collection date for primary outcome measure)

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.
Both
40 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01020266
XJMZK015
Yes
Lize Xiong, Chairman of Department of Anesthesilogy, Xijing Hospital, Fourth Military Medical University
Xijing Hospital
Fourth Military Medical University
Study Director: Aideng Weng, Ph.D. Xijing Hospital
Xijing Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP