Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by TEAS
Condition: Immunosuppression
Study type: Interventional

Summary: 
      The coronary artery bypass grafting (CABG) is a surgery to relieve angina and reduce
      mortality of coronary heart disease. However, the patient is more prone to have
      immunosuppression after the surgery, causing secondary infection, and it is closely
      correlated to the occurrence and progress of tumor after surgery. More and more studies
      revealed that needle puncture was able to effectively regulate the function of immune system.
      However, its perioperative application is unclear. Therefore, this clinical study is aimed to
      evaluate whether the effect of transcutaneous acupoint electric stimulation (TEAS) on
      improvement of immunosuppression of patients after receiving CABG.
    

Detailed description: 
      This clinical study was a single-center clinical trial. The 88 patients scheduled to receive
      CABG under CPB were randomized into 2 groups: the group of TEAS, and the group of
      transcutaneous acupoint pseudo - electric stimulation (Sham TEAS). Monocytic HLA-DR
      expression serves as a primary endpoint, and other laboratory parameters (e.g. IL-6, IL-10)
      and clinical outcomes (e.g. postoperative infectious complications, ICU stay time, and
      mortality) as the secondary endpoints. In addition, some immune indicators, such as high
      mobility group protein 1 (HMGB1) and regulatory T cell (Treg), possibly related to the
      mechanism of TEAS, will also be measured.

      This study is a preliminary, mono-center, double-blind, randomized and controlled clinical
      trial (number of sample, n=88) to explore the effects of TEAS therapy on improvement of
      postoperative immunosuppression indicated by diminished HLA-DR expression of patients
      receiving CABG (Fig. 1). The trial will be commenced after ethical approval has been obtained
      from the Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of
      Traditional Chinese Medicine. All study-related procedures will be performed only after
      subjects have given their written informed consent. The trial is designed following the
      Consolidated Standards of Reporting Trials (CONSORT) guidelines, the Standard Protocol Items:
      Recommendations for Interventional Trials (SPIRIT) Checklist (Additional file 1), and
      Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA)
      recommendations.

      We calculate the sample size from the pilot study in our hospital based on the primary
      outcome Human leukocyte antigen of monocyte (mHLA-DR). In the study, the expression of
      mHLA-DR three days after surgery was (36.17±5.42) % in the TEAS group and (27.33±3.50) % in
      the Sham TEAS group, with a power of 80% and 5% Type I error rate. Assuming that the dropout
      rate to be 10%, 88 patients (n=44 for each group) are needed.

      Patients will be recruited from the department of Thoracic and Cardiovascular surgery, at
      Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.
      Potentially eligible subjects who have scheduled for CABG under CPB for coronary diseases
      will be invited to participate. Patients will be referred from a cardiothoracic surgeon, and
      then a research assistant will approach the subjects in the general ward pre operation.
      Patients will be screened and consented for the study. Following the consent, eligible
      participants will be block randomized into two groups: ⑴ TEAS group (n=44) and ⑵ sham TEAS
      group (n=44). All patients will conduct a standard operative procedure and postoperative
      analgesia management. The patients of TEAS group will receive TEAS therapy in perioperative
      period, and the Sham TEAS will not be performed to receive electrical stimulation sensation
      in perioperative period. Assessments will be conducted during the perioperative period until
      30 days after surgery.
    

Intervention name(s): TEAS+GA group; Sham TEAS+GA group
Intervention type(s): Device; Device
Intervention description(s): The acupoints including Zusanli and Shenshu, were identified before electrical stimulation with surface electrodes. Selection of these acupoints was based on a consensus between the acupuncturists of the study.; No electrical stimulation sensation is performed in the Sham TEAS group. In the Sham TEAS group, pseudo-stimulation is provided by deliberately connecting the electrodes to the incorrect output socket of the electroacupuncture device, and thus there is no flow of electric current. Patients could see the output light flashing but no current was transmitted throughout the procedure. Patients would be told that the stimulation frequency selected was not perceivable by human beings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: immunosuppression; cardiac surgery; TEAS(Transcutaneous electrical acupoint stimulation); postoperative