Clinical trial NCT01020266: Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery
Official title: Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Injuries
Keywords: brain protection
cardiac surgery
heart valve replacement
electroacupuncture
pretreatment
preconditioning
Thoracic Surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Air Force Military Medical University, China
First posted: 2009-11-25
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cerebrovascular complications and Score of neurological defect
timeFrame: before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment
Secondary outcomes:
measure: The S-100B and NSE blood level
timeFrame: before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Aideng Weng, Ph.D.
role: STUDY_DIRECTOR
References: