Neuroprotective Study of Electroacupuncture Pretreatment in Patients Undergoing Cardiac Surgery

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020266
• Other study ID #: XJMZK015
• Status: Completed
• Phase: N/A
• First received: November 22, 2009
• Last updated: June 23, 2015
• Start date: December 2009
• Est. completion date: June 2013

Study information

• Verified date: November 2009
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Injuries
• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (2)

Lead Sponsor	Collaborator
Xijing Hospital	Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular complications and Score of neurological defect		before treatment, after the first treatment, 7, 28days after treatment and follow up at 6 months after treatment	Yes
Secondary	The S-100B and NSE blood level		before treatment, after the last treatment, before surgery, and the first 72 hours of surgery follow-up	No