Abstract
Abstract
Background: Cardiac surgery involving cardiopulmonary bypass (CPB) is known to be associated with a transient postoperative immunosuppression. When severe and persistent, this immune dysfunction predisposes patients to infectious complications, which contributes to a prolonged stay in the intensive care unit (ICU), even mortality. The effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture related techniques, such as electroacupuncture (EA) and transcutaneous electrical acupoint stimulation (TEAS), are able to produce effective cardioprotection and immunomodulation in adult and pediatric patients undergoing cardiac surgery with CPB, which leads to enhanced recovery. However, whether perioperative application of TEAS, a non-invasive technique, is able to improve immunosuppression of the patients with post cardiosurgical conditions is unknown. Thus, as a preliminary study, the main objective is to evaluate the effects of TEAS on the postoperative expression of monocytic human leukocyte antigen (-D related) (mHLA-DR), a standardized “global” biomarker of injury or sepsis-associated immunosuppression, in patients receiving on-pump CABG.
Methods: 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.
Discussion: The current study is a preliminary mono-centric clinical trial with a non-clinical primary endpoint, expression of mHLA-DR, aiming at determining whether perioperative application of TEAS has a potential to reverse CABG-associated immunosuppression. Although the immediate clinical impact of this study is limited, its results would inform further large sample clinical trial with using relevant patient-centered clinical outcomes as primary endpoints.
Trial registration: This study was approved by Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine with the number 2016-455-06-01. The results of the trial will be published in an internationally peer-reviewed journal. This study was registered at ClinicalTrials with the Identifier NCT02933996 on 13 October 2016, https://www.clinicaltrials.gov/ct2/show/NCT02933996
Keywords: CABG; TEAS; immunosuppression; mHLA-DR
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
