ImmunosuppressionNCT02933996
Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by TEAS
A study testing TEAS+GA group in people with Immunosuppression, run by ShuGuang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Immunosuppression
- What is being tested?
- TEAS+GA group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2017to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203
About this study
Official title: Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by Transcutaneous Electrical Acupoint Stimulation: Study Protocol for a Double-blind Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Immunosuppression
- Being tested
- TEAS+GA group, Sham TEAS+GA group
- Keywords
- immunosuppression, cardiac surgery, TEAS(Transcutaneous electrical acupoint stimulation), postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAS+GA groupDevice
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 groupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TEAS+GA group | Experimental | The patients of TEAS+GA group will receive TEAS therapy in perioperative period.
GA: general anesthesia Receives: 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. Receives: Device: TEAS+GA group; Device: Sham TEAS+GA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of mHLA-DR positive cell
Human leukocyte antigen of monocyte (mHLA-DR)
Measured: 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
interleukin-6 (IL-6)
Measured: One day before surgery, Day 1, 3 and 5 after surgery
Content of serum CRP
reactive protein C (CRP)
Measured: One day before surgery, Day 1, 3 and 5 after surgery
Rate of secondary infection
observe the incidence of incision infection, lung infection, hematogenous infection and indwelled catheter infection after the surgery
Measured: Within 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study start1 Dec 2017
- Primary completion29 Feb 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- ShuGuang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Responsible party
- Principal investigator, Jiangang Song, ShuGuang Hospital
- Investigators
- Jianggang Song, M.D., Principal investigator, Shuguang Hospital Affiliated to Shanghai University of TCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933996
- Sponsor's protocol ID
- 14401932600
- Status last verified
- May 2020
- First submitted
- 10 Oct 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol will be shared with other researchers.
Publications
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.
PubMed 31888744
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Postoperative Immunosuppression in Patients Receiving Coronary Artery Bypass Grafting by Transcutaneous Electrical Acupoint Stimulation: Study Protocol for a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02933996
- Acronym / sponsor ID
- 14401932600
- Conditions
- Immunosuppression
- Keywords
- immunosuppression, cardiac surgery, TEAS(Transcutaneous electrical acupoint stimulation), postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- ShuGuang HospitalUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 14 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEAS+GA group | Experimental | Device: TEAS+GA group, Device: Sham TEAS+GA groupThe patients of TEAS+GA group will receive TEAS therapy in perioperative period. GA: general anesthesia |
| Sham TEAS+GA group | Sham comparator | Device: TEAS+GA group, Device: Sham TEAS+GA groupThe patients of Sham TEAS+GA will receive none TEAS in perioperative period. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAS+GA groupThe 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. | Device | Sham TEAS+GA group, TEAS+GA group |
| Sham TEAS+GA groupNo 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. | Device | Sham TEAS+GA group, TEAS+GA group |
Primary outcome
Proportion of mHLA-DR positive cell
Time frame: 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).
Human leukocyte antigen of monocyte (mHLA-DR)
3 secondary outcomes
Content of serum IL-6
Time frame: One day before surgery, Day 1, 3 and 5 after surgery
Content of serum CRP
Time frame: One day before surgery, Day 1, 3 and 5 after surgery
Rate of secondary infection
Time frame: Within 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Derived from this study: PubMed 31888744Chen 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.
- Individual participant dataSharing planned: Yes. Study Protocol will be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianggang Song, M.D. principal investigator
Shuguang Hospital Affiliated to Shanghai University of TCM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAS+GA group in people with Immunosuppression, run by ShuGuang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of mHLA-DR positive cell (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02933996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2020.