Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
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|ClinicalTrials.gov Identifier: NCT01020266|
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : June 25, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stroke Brain Injuries||Procedure: non electroacupuncture stimulation Procedure: Electroacupuncture pretreatment||Not Applicable|
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.
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||June 2013|
|Active Comparator: Electroacupuncture||
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．
|Sham Comparator: Control||
Procedure: non electroacupuncture stimulation
The same procedure as electroacupuncture except stimulation
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020266
|Xi'an, Shaanxi, China, 710032|
|Study Director:||Aideng Weng, Ph.D.||Xijing Hospital|