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
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 in...
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| Format: | Article |
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BMC
2019-12-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-019-3889-z |
| _version_ | 1818364116999340032 |
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| author | Wen-ting Chen Jin-feng Wei Lan Wang Deng-wen Zhang Wei Tang Jian Wang Yue Yong Jing Wang Ya-lan Zhou Lan Yuan Guo-qiang Fu Sheng Wang Jian-gang Song |
| author_facet | Wen-ting Chen Jin-feng Wei Lan Wang Deng-wen Zhang Wei Tang Jian Wang Yue Yong Jing Wang Ya-lan Zhou Lan Yuan Guo-qiang Fu Sheng Wang Jian-gang Song |
| author_sort | Wen-ting Chen |
| collection | DOAJ |
| description | 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), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture 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 coronary artery bypass grafting (CABG). Methods This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured. Discussion The current study is a preliminary monocentric 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 trials using relevant patient-centered clinical outcomes as primary endpoints. Trial registration ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016. |
| first_indexed | 2024-12-13T21:59:16Z |
| format | Article |
| id | doaj.art-f5700eb491214a2a897a7e69d2db1915 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-13T21:59:16Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-f5700eb491214a2a897a7e69d2db19152022-12-21T23:30:04ZengBMCTrials1745-62152019-12-0120111210.1186/s13063-019-3889-zEffects 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 trialWen-ting Chen0Jin-feng Wei1Lan Wang2Deng-wen Zhang3Wei Tang4Jian Wang5Yue Yong6Jing Wang7Ya-lan Zhou8Lan Yuan9Guo-qiang Fu10Sheng Wang11Jian-gang Song12Anesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineGuangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical SciencesAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineGuangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical SciencesAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineGuangdong Cardiovascular Institute & Guangdong General Hospital, Guangdong Academy of Medical SciencesAnesthesiology Department, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese MedicineAbstract 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), and even mortality. Effective prevention and treatment methods are still lacking. Recent studies revealed that acupuncture-related techniques, such as electroacupuncture 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 coronary artery bypass grafting (CABG). Methods This study is a single-center clinical trial. The 88 patients scheduled to receive CABG under CPB will be randomized into two groups: the group receiving TEAS, and the group receiving transcutaneous acupoint pseudo-electric stimulation (Sham TEAS). Expression of mHLA-DR serves as a primary endpoint, and other laboratory parameters (e.g., interleukin [IL]-6, IL-10) and clinical outcomes (e.g., postoperative infectious complications, ICU stay time, and mortality) as the secondary endpoints. In addition, immune indicators, such as high mobility group box 1 protein and regulatory T cells will also be measured. Discussion The current study is a preliminary monocentric 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 trials using relevant patient-centered clinical outcomes as primary endpoints. Trial registration ClinicalTrials.gov, NCT02933996. Registered on 13 October 2016.https://doi.org/10.1186/s13063-019-3889-zCABGTEASImmunosuppressionmHLA-DR |
| spellingShingle | Wen-ting Chen Jin-feng Wei Lan Wang Deng-wen Zhang Wei Tang Jian Wang Yue Yong Jing Wang Ya-lan Zhou Lan Yuan Guo-qiang Fu Sheng Wang Jian-gang Song 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 CABG TEAS Immunosuppression mHLA-DR |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | CABG TEAS Immunosuppression mHLA-DR |
| url | https://doi.org/10.1186/s13063-019-3889-z |
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