Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by TEAS

NCT02933996 | Completed DMC

• 1 other identifier: 14401932600
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunosuppression

Keywords

immunosuppression; cardiac surgery; TEAS(Transcutaneous electrical acupoint stimulation); postoperative

Outcome Measures

Primary Outcomes (1)

• Proportion of mHLA-DR positive cell

  Human leukocyte antigen of monocyte (mHLA-DR)

  day before surgery, Day 1 after surgery (one day after surgery), Day 3 after surgery (3 days after surgery), and Day 5 after surgery (5 days after surgery).

Secondary Outcomes (3)

• Content of serum IL-6

  One day before surgery, Day 1, 3 and 5 after surgery

• Content of serum CRP

  One day before surgery, Day 1, 3 and 5 after surgery

• Rate of secondary infection

  Within 7 days after surgery

Study Arms (2)

TEAS+GA group

EXPERIMENTAL

The patients of TEAS+GA group will receive TEAS therapy in perioperative period. GA: general anesthesia

Device: TEAS+GA group; Device: Sham TEAS+GA group

Sham TEAS+GA group

SHAM COMPARATOR

The patients of Sham TEAS+GA will receive none TEAS in perioperative period.

Device: TEAS+GA group; Device: Sham TEAS+GA group

Interventions

TEAS+GA group DEVICE

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.

Sham TEAS+GA group; TEAS+GA group

Sham TEAS+GA group DEVICE

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.

Sham TEAS+GA group; TEAS+GA group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, male and female;
• Patients diagnosed as coronary disease, scheduled to receive CABG;
• BMI: 18.5kg/m2\<BMI≤30kg/m2；
• Graded as I-III by American Standards Association(ASA);
• Patients firstly receiving CABG under extracorporeal circulation.

You may not qualify if:

• Presence of surgical incision or scar at Zusanli acupoint (ST36) /Shenshu (BL23) acupoint;
• Patients with local skin infection at acupoint;
• Patients with nerve injury on upper or lower limbs;
• Patients with history of spinal surgery;
• Patients who have participated in other clinical trial in recent 4 weeks;
• Patients using pacemaker;
• Patients combined with pain before surgery who are using central analgesic drug or drug abuser (e.g., opioid) and dependent user;
• Patients combined with severe central nervous system disease or severe mental disease;
• Patients with alcoholic history;
• Patients who have received emergent coronary bypass operation due to acute myocardial infarction.

Sponsors & Collaborators

• ShuGuang Hospital: lead
• Guangdong Provincial People's Hospital: collaborator

Study Sites (1)

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 201203, China

Location

Related Publications (1)

• Chen WT, Wei JF, Wang L, Zhang DW, Tang W, Wang J, Yong Y, Wang J, Zhou YL, Yuan L, Fu GQ, Wang S, Song JG. Effects of perioperative transcutaneous electrical acupoint stimulation on monocytic HLA-DR expression in patients undergoing coronary artery bypass grafting with cardiopulmonary bypass: study protocol for a double-blind randomized controlled trial. Trials. 2019 Dec 30;20(1):789. doi: 10.1186/s13063-019-3889-z.

  PMID: 31888744 DERIVED

Study Officials

• Jianggang Song, M.D.

  Shuguang Hospital Affiliated to Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: deputy director of anesthesia

Study Record Dates

• First Submitted: October 10, 2016
• First Posted: October 14, 2016
• Study Start: December 1, 2017
• Primary Completion: February 29, 2020
• Study Completion: March 31, 2020
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available with 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an extemal independent Review Panel. Requestors will be required to sign a Data Access Agreement.

Locations

CN (1)