Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
NCT ID: NCT01020266
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2009-12-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Electroacupuncture
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．
Control
non electroacupuncture stimulation
The same procedure as electroacupuncture except stimulation
Interventions
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non electroacupuncture stimulation
The same procedure as electroacupuncture except stimulation
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients would like to accept the follow-up and sign the informed consent
* patients with heart function of NYHA I-III degree.
Exclusion Criteria
* 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.
40 Years
65 Years
ALL
No
Sponsors
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Air Force Military Medical University, China
OTHER
Xijing Hospital
OTHER
Responsible Party
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Principal Investigators
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Aideng Weng, Ph.D.
Role: STUDY_DIRECTOR
Xijing Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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Other Identifiers
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XJMZK015
Identifier Type: -
Identifier Source: org_study_id
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