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
  Purpose

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.


Condition Intervention
Stroke
Brain Injuries
Procedure: non electroacupuncture stimulation
Procedure: Electroacupuncture pretreatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Trial of Cerebral Protective Effects of Repeated Electroacupuncture Pretreatment in Heart Valve Replacement Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Acupuncture
  • preconditioning
  • electric stimulation
Sham Comparator: Control Procedure: non electroacupuncture stimulation
The same procedure as electroacupuncture except stimulation

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

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020266

Locations
China, Shaanxi
Xijing Hospital
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Fourth Military Medical University
Investigators
Study Director: Aideng Weng, Ph.D. Xijing Hospital
  More Information

No publications provided

Responsible Party: Lize Xiong, Chairman of Department of Anesthesilogy, Xijing Hospital, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT01020266     History of Changes
Other Study ID Numbers: XJMZK015
Study First Received: November 22, 2009
Last Updated: November 23, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
brain protection
cardiac surgery
heart valve replacement
electroacupuncture
pretreatment
preconditioning
Thoracic Surgery
Cardiac Surgery

Additional relevant MeSH terms:
Stroke
Brain Injuries
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 28, 2014