Systemic Inflammatory Response Syndrome (SIRS)EAST36-CPBNCT07795112
Electroacupuncture at ST36 for Reducing Postoperative Inflammation After Cardiac Surgery With Cardiopulmonary Bypass
A study testing Electroacupuncture at Bilateral ST36 and Acupuncture Without Electrical Stimulation at Bilateral ST36 in people with Systemic Inflammatory Response Syndrome (SIRS) and Cardiac Surgical Procedures, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
Cardiac surgery using cardiopulmonary bypass can trigger a marked systemic inflammatory response and may contribute to postoperative organ dysfunction and delayed recovery. Electroacupuncture at the Zusanli acupoint (ST36) may regulate inflammatory responses, but its clinical effects in patients undergoing cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome (SIRS), Cardiac Surgical Procedures, Postoperative Complications (Cardiopulmonary)
- What is being tested?
- Electroacupuncture at Bilateral ST36 and Acupuncture Without Electrical Stimulation at Bilateral ST36
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Scheduled to undergo elective cardiac surgery with cardiopulmonary bypass (CPB) support.
- The surgical procedure may include coronary artery bypass grafting (CABG), valve replacement, valve repair, or another cardiac surgical procedure performed with CPB support.
- Voluntarily agrees to participate in the study and provides written informed consent. If a participant is unable to read and sign the informed consent form because of incapacity or another reason, the informed consent process will be conducted with the participant's legally authorized representative, who will sign on the participant's behalf. If a participant is unable to read the informed consent form, the informed consent process will be witnessed by an independent witness, who will sign the informed consent form.
Who cannot join
- Membership in a vulnerable population other than older adults or individuals who are illiterate, including patients with psychiatric disorders, cognitive impairment, critical illness, or another vulnerable condition.
- Pregnant or breastfeeding.
- Local skin or soft-tissue infection, erysipelas, or another condition at the acupuncture site that makes acupuncture treatment unsuitable.
- History of organ transplantation.
- Active malignancy.
- Long-term high-dose corticosteroid therapy before surgery, defined as prednisone ≥20 mg/day for ≥14 days or a cumulative prednisone-equivalent dose >700 mg.
Show all 15Show fewer
- Severe chronic organ dysfunction before surgery, including any of the following:
- Chronic respiratory disease with a baseline PaO₂/FiO₂ ratio <300.
- Hematological disease, such as leukemia, lymphoma, or myeloma, or a baseline platelet count <100 × 10⁹/L.
- Chronic liver disease with total bilirubin >30 μmol/L.
- History of stroke or cerebral hemorrhage with a baseline Glasgow Coma Scale score <10.
- Chronic renal insufficiency with serum creatinine >110 μmol/L or long-term daily urine output <500 mL.
- Unable to tolerate electroacupuncture treatment.
- Currently participating in another interventional clinical study.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
About this study
Official title: Effect of Electroacupuncture at Bilateral Zusanli (ST36) on Postoperative Inflammatory Response and Organ Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective, Randomized, Parallel-Controlled Trial
Cardiac surgery using cardiopulmonary bypass can trigger a marked systemic inflammatory response and may contribute to postoperative organ dysfunction and delayed recovery. Electroacupuncture at the Zusanli acupoint (ST36) may regulate inflammatory responses, but its clinical effects in patients undergoing cardiac surgery remain uncertain.
This prospective, randomized, parallel-group study will enroll 140 adults undergoing elective cardiac surgery with cardiopulmonary bypass. After surgery and admission to the intensive care unit, participants will be randomly assigned in a 1:1 ratio to receive either bilateral ST36 electroacupuncture or a control procedure involving the same acupoint localization, skin disinfection, needle insertion, and needle retention without electrical stimulation. Both groups will receive standard postoperative care. The intervention will be administered twice for 30 minutes per session.
The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary outcomes include the duration of vasoactive drug use, incidence and severity of systemic inflammatory response syndrome, duration of mechanical ventilation, length of intensive care unit and hospital stay, and perioperative inflammatory markers. The study will evaluate whether ST36 electroacupuncture can reduce postoperative inflammation and organ injury and improve recovery after cardiac surgery.
Read the detailed description
Cardiopulmonary bypass, surgical trauma, and ischemia-reperfusion injury can induce a systemic inflammatory response after cardiac surgery. Excessive inflammation is associated with postoperative organ dysfunction and adverse clinical outcomes. Preclinical evidence suggests that electroacupuncture at ST36 may modulate systemic inflammation through neuroimmune pathways, including the vagal-adrenal axis. However, its clinical effectiveness in patients undergoing cardiac surgery with cardiopulmonary bypass has not been established.
Eligible participants will be randomized after returning to the intensive care unit following surgery. Participants in the experimental group will receive bilateral ST36 electroacupuncture in addition to standard postoperative treatment and nursing care. Electroacupuncture will be administered twice, with each session lasting 30 minutes. Participants in the control group will receive the same standard postoperative care and the same acupoint localization, skin disinfection, needle insertion, and needle retention procedures, but without electrical stimulation.
The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary assessments include vasoactive drug use, systemic inflammatory response syndrome, mechanical ventilation, intensive care unit and hospital length of stay, inflammatory cytokines, and other laboratory indicators of inflammation and organ function. The primary analysis will follow the intention-to-treat principle.
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Cardiac Surgical Procedures, Postoperative Complications (Cardiopulmonary)
- Being tested
- Electroacupuncture at Bilateral ST36, Acupuncture Without Electrical Stimulation at Bilateral ST36
- Keywords
- Electroacupuncture, Zusanli, ST36, Cardiopulmonary Bypass, Postoperative Inflammation, Sequential Organ Failure Assessment, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroacupuncture at Bilateral ST36Other
Participants assigned to the experimental group will receive electroacupuncture at bilateral Zusanli (ST36) after cardiac surgery and admission to the intensive care unit. Electrical stimulation will be applied through acupuncture needles placed at bilateral ST36. The intervention will be administered twice, with each session lasting 30 minutes, in addition to standard postoperative treatment and nursing care.
Acupuncture Without Electrical Stimulation at Bilateral ST36Other
Participants assigned to the control group will receive the same bilateral ST36 acupoint localization, skin disinfection, needle insertion, and needle retention procedures as the experimental group, but without electrical stimulation. The control procedure will be administered twice, with each session lasting 30 minutes, in addition to standard postoperative treatment and nursing care.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture Group | Experimental | Not described Receives: Other: Electroacupuncture at Bilateral ST36 |
| Acupuncture Without Electrical Stimulation Group | Sham comparator | Not described Receives: Other: Acupuncture Without Electrical Stimulation at Bilateral ST36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-Reactive Protein Level on Postoperative Day 2
Serum C-reactive protein concentration measured in milligrams per liter (mg/L). The primary analysis will compare C-reactive protein levels between the two study groups.
Measured: Postoperative day 2
Sequential Organ Failure Assessment Score on Postoperative Day 2
The Sequential Organ Failure Assessment (SOFA) score assesses dysfunction across six organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal. Each organ system is scored from 0 to 4, and the six component scores are summed to produce a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and therefore a worse outcome.
Measured: Postoperative day 2
Secondary outcomes (5)
Duration of Vasoactive Drug Use
The outcome is defined as the total cumulative duration, measured in hours, of continuous intravenous norepinephrine and/or epinephrine administration during the postoperative intensive care unit (ICU) stay. Drug administration start and stop times will be obtained from the nursing medication administration records. The observation period begins at postoperative ICU admission and ends at ICU discharge.
Measured: The outcome is defined as the total cumulative duration, measured in hours, of continuous intravenous norepinephrine and/or epinephrine administration during the postoperative ICU stay, an average of 2 days.
Systemic Inflammatory Response Syndrome Score
The Systemic Inflammatory Response Syndrome (SIRS) score is calculated using four criteria: (1) body temperature greater than 38°C or less than 36°C; (2) heart rate greater than 90 beats per minute; (3) respiratory rate greater than 20 breaths per minute or arterial partial pressure of carbon dioxide (PaCO2) less than 32 mmHg; and (4) white blood cell count greater than 12,000/µL, less than 4,000/µL, or greater than 10% immature band forms. Each criterion present is assigned 1 point, producing a total score ranging from 0 to 4. Higher scores indicate a greater systemic inflammatory response and therefore a worse outcome. A total score of 2 or higher is considered positive for SIRS. The maximum SIRS score for each postoperative ICU day will be determined using the most abnormal values documented during that day.
Measured: Postoperative day 2
Duration of Mechanical Ventilation
The outcome is defined as the total cumulative duration, measured in hours, during which the participant receives invasive mechanical ventilation from postoperative intensive care unit (ICU) admission until ICU discharge. The start and stop times of mechanical ventilation will be obtained from the nursing records. If a participant is extubated and subsequently reintubated during the same ICU stay, the durations of all invasive mechanical ventilation episodes will be summed. Time between ventilation episodes will not be counted.
Measured: From postoperative ICU admission until final successful extubation, an average of 2 days.
Intensive Care Unit Length of Stay
Postoperative intensive care unit (ICU) length of stay is defined as the elapsed time, measured in days, from the documented time of postoperative ICU admission to the documented time of ICU discharge or transfer out of the ICU.
Measured: From postoperative ICU admission until ICU discharge, an average of 4 days
Hospital Length of Stay
Postoperative hospital length of stay is defined as the elapsed time, measured in days, from the documented time of postoperative ICU admission until discharge from the hospital. The duration will be calculated using the ICU admission and hospital discharge timestamps recorded in the hospital records
Measured: From postoperative ICU admission until hospital discharge, an average of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Systemic Inflammatory Response Syndrome (SIRS)Studies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-cang Zhou M.D., Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07795112
- Sponsor's protocol ID
- SRRSH2026-0762
- Other IDs
- MR-33-26-061297
- Acronym
- EAST36-CPB
- Status last verified
- Aug 2026
- First submitted
- 15 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Toner AJ, Corcoran TB, Vlaskovsky PS, Nierich AP, Bain CR, Dieleman JM. Inflammation risk before cardiac surgery and the treatment effect of intraoperative dexamethasone. Anaesth Intensive Care. 2024 Jan;52(1):28-36. doi: 10.1177/0310057X231195098. Epub 2023 Nov 24.
PubMed 38000008Taddei S, Virdis A, Ghiadoni L, Magagna A, Salvetti A. Vitamin C improves endothelium-dependent vasodilation by restoring nitric oxide activity in essential hypertension. Circulation. 1998 Jun 9;97(22):2222-9. doi: 10.1161/01.cir.97.22.2222.
PubMed 9631871Muhammad M, Jahangir A, Kassem A, Sattar SBA, Jahangir A, Sahra S, Niazi MRK, Mustafa A, Zia Z, Siddiqui FS, Sadiq W, Mishiyev D, Sammar A, Dahabra L, Irshad A, Elsayegh D, Chalhoub M. The Role and Efficacy of Vitamin C in Sepsis: A Systematic Review and Meta-Analysis. Adv Respir Med. 2022 Jul 28;90(4):281-299. doi: 10.3390/arm90040038.
PubMed 36004958Hill KD, Kannankeril PJ, Jacobs JP, Baldwin HS, Jacobs ML, O'Brien SM, Bichel DP, Graham EM, Blasiole B, Resheidat A, Husain AS, Kumar SR, Kirchner JL, Gallup DS, Turek JW, Bleiweis M, Mettler B, Benscoter A, Wald E, Karamlou T, Van Bergen AH, Overman D, Eghtesady P, Butts R, Kim JS, Scott JP, Anderson BR, Swartz MF, McConnell PI, Vener DF, Li JS; STRESS Network Investigators. Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial. N Engl J Med. 2022 Dec 8;387(23):2138-2149. doi: 10.1056/NEJMoa2212667. Epub 2022 Nov 6.
PubMed 36342116Ott S, Lee ZY, Muller-Wirtz LM, Cangut B, Roessler J, Patterson W, Thomas CM, Bekele BM, Windpassinger M, Lobdell K, Grant MC, Arora RC, Engelman DT, Fremes S, Velten M, O'Brien B, Ruetzler K, Heyland DK, Stoppe C. The effect of a selenium-based anti-inflammatory strategy on postoperative functional recovery in high-risk cardiac surgery patients - A nested sub-study of the sustain CSX trial. Life Sci. 2024 Aug 15;351:122841. doi: 10.1016/j.lfs.2024.122841. Epub 2024 Jun 17.
PubMed 38897349Stoppe C, McDonald B, Meybohm P, Christopher KB, Fremes S, Whitlock R, Mohammadi S, Kalavrouziotis D, Elke G, Rossaint R, Helmer P, Zacharowski K, Gunther U, Parotto M, Niemann B, Boning A, Mazer CD, Jones PM, Ferner M, Lamarche Y, Lamontagne F, Liakopoulos OJ, Cameron M, Muller M, Zarbock A, Wittmann M, Goetzenich A, Kilger E, Schomburg L, Day AG, Heyland DK; SUSTAIN CSX Study Collaborators. Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial. JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.
PubMed 36630120Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.
PubMed 23117776Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13.
PubMed 34646018Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
PubMed 32791039Torres-Rosas R, Yehia G, Pena G, Mishra P, del Rocio Thompson-Bonilla M, Moreno-Eutimio MA, Arriaga-Pizano LA, Isibasi A, Ulloa L. Dopamine mediates vagal modulation of the immune system by electroacupuncture. Nat Med. 2014 Mar;20(3):291-5. doi: 10.1038/nm.3479. Epub 2014 Feb 23.
PubMed 24562381Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.
PubMed 11825729Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
PubMed 22998715Laffey JG, Boylan JF, Cheng DC. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology. 2002 Jul;97(1):215-52. doi: 10.1097/00000542-200207000-00030. No abstract available.
PubMed 12131125
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture at Bilateral Zusanli (ST36) on Postoperative Inflammatory Response and Organ Injury in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: A Prospective, Randomized, Parallel-Controlled Trial
- ClinicalTrials.gov ID
- NCT07795112
- Acronym / sponsor ID
- EAST36-CPB / SRRSH2026-0762
- Conditions
- Systemic Inflammatory Response Syndrome (SIRS), Cardiac Surgical Procedures, Postoperative Complications (Cardiopulmonary)
- Keywords
- Electroacupuncture, Zusanli, ST36, Cardiopulmonary Bypass, Postoperative Inflammation, Sequential Organ Failure Assessment, Systemic Inflammatory Response Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- 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.
Cardiac surgery using cardiopulmonary bypass can trigger a marked systemic inflammatory response and may contribute to postoperative organ dysfunction and delayed recovery. Electroacupuncture at the Zusanli acupoint (ST36) may regulate inflammatory responses, but its clinical effects in patients undergoing cardiac surgery remain uncertain.
This prospective, randomized, parallel-group study will enroll 140 adults undergoing elective cardiac surgery with cardiopulmonary bypass. After surgery and admission to the intensive care unit, participants will be randomly assigned in a 1:1 ratio to receive either bilateral ST36 electroacupuncture or a control procedure involving the same acupoint localization, skin disinfection, needle insertion, and needle retention without electrical stimulation. Both groups will receive standard postoperative care. The intervention will be administered twice for 30 minutes per session.
The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary outcomes include the duration of vasoactive drug use, incidence and severity of systemic inflammatory response syndrome, duration of mechanical ventilation, length of intensive care unit and hospital stay, and perioperative inflammatory markers. The study will evaluate whether ST36 electroacupuncture can reduce postoperative inflammation and organ injury and improve recovery after cardiac surgery.
Detailed description
Cardiopulmonary bypass, surgical trauma, and ischemia-reperfusion injury can induce a systemic inflammatory response after cardiac surgery. Excessive inflammation is associated with postoperative organ dysfunction and adverse clinical outcomes. Preclinical evidence suggests that electroacupuncture at ST36 may modulate systemic inflammation through neuroimmune pathways, including the vagal-adrenal axis. However, its clinical effectiveness in patients undergoing cardiac surgery with cardiopulmonary bypass has not been established.
Eligible participants will be randomized after returning to the intensive care unit following surgery. Participants in the experimental group will receive bilateral ST36 electroacupuncture in addition to standard postoperative treatment and nursing care. Electroacupuncture will be administered twice, with each session lasting 30 minutes. Participants in the control group will receive the same standard postoperative care and the same acupoint localization, skin disinfection, needle insertion, and needle retention procedures, but without electrical stimulation.
The primary outcomes are C-reactive protein levels and Sequential Organ Failure Assessment scores on postoperative day 2. Secondary assessments include vasoactive drug use, systemic inflammatory response syndrome, mechanical ventilation, intensive care unit and hospital length of stay, inflammatory cytokines, and other laboratory indicators of inflammation and organ function. The primary analysis will follow the intention-to-treat principle.
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 |
|---|---|---|
| Electroacupuncture Group | Experimental | Other: Electroacupuncture at Bilateral ST36 |
| Acupuncture Without Electrical Stimulation Group | Sham comparator | Other: Acupuncture Without Electrical Stimulation at Bilateral ST36 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Scheduled to undergo elective cardiac surgery with cardiopulmonary bypass (CPB) support.
- The surgical procedure may include coronary artery bypass grafting (CABG), valve replacement, valve repair, or another cardiac surgical procedure performed with CPB support.
- Voluntarily agrees to participate in the study and provides written informed consent. If a participant is unable to read and sign the informed consent form because of incapacity or another reason, the informed consent process will be conducted with the participant's legally authorized representative, who will sign on the participant's behalf. If a participant is unable to read the informed consent form, the informed consent process will be witnessed by an independent witness, who will sign the informed consent form.
Key exclusion criteria (15 listed)
- Membership in a vulnerable population other than older adults or individuals who are illiterate, including patients with psychiatric disorders, cognitive impairment, critical illness, or another vulnerable condition.
- Pregnant or breastfeeding.
- Local skin or soft-tissue infection, erysipelas, or another condition at the acupuncture site that makes acupuncture treatment unsuitable.
- History of organ transplantation.
- Active malignancy.
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 |
|---|---|---|
| Electroacupuncture at Bilateral ST36Participants assigned to the experimental group will receive electroacupuncture at bilateral Zusanli (ST36) after cardiac surgery and admission to the intensive care unit. Electrical stimulation will be applied through acupuncture needles placed at bilateral ST36. The intervention will be administered twice, with each session lasting 30 minutes, in addition to standard postoperative treatment and nursing care. | Other | Electroacupuncture Group |
| Acupuncture Without Electrical Stimulation at Bilateral ST36Participants assigned to the control group will receive the same bilateral ST36 acupoint localization, skin disinfection, needle insertion, and needle retention procedures as the experimental group, but without electrical stimulation. The control procedure will be administered twice, with each session lasting 30 minutes, in addition to standard postoperative treatment and nursing care. | Other | Acupuncture Without Electrical Stimulation Group |
Primary outcome
C-Reactive Protein Level on Postoperative Day 2
Time frame: Postoperative day 2
Serum C-reactive protein concentration measured in milligrams per liter (mg/L). The primary analysis will compare C-reactive protein levels between the two study groups.
Sequential Organ Failure Assessment Score on Postoperative Day 2
Time frame: Postoperative day 2
The Sequential Organ Failure Assessment (SOFA) score assesses dysfunction across six organ systems: respiratory, coagulation, liver, cardiovascular, central nervous system, and renal. Each organ system is scored from 0 to 4, and the six component scores are summed to produce a total score ranging from 0 to 24. Higher scores indicate more severe organ dysfunction and therefore a worse outcome.
5 secondary outcomes
Duration of Vasoactive Drug Use
Time frame: The outcome is defined as the total cumulative duration, measured in hours, of continuous intravenous norepinephrine and/or epinephrine administration during the postoperative ICU stay, an average of 2 days.
Systemic Inflammatory Response Syndrome Score
Time frame: Postoperative day 2
Duration of Mechanical Ventilation
Time frame: From postoperative ICU admission until final successful extubation, an average of 2 days.
Intensive Care Unit Length of Stay
Time frame: From postoperative ICU admission until ICU discharge, an average of 4 days
Hospital Length of Stay
Time frame: From postoperative ICU admission until hospital discharge, an average of 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Results publication: PubMed 38000008Toner AJ, Corcoran TB, Vlaskovsky PS, Nierich AP, Bain CR, Dieleman JM. Inflammation risk before cardiac surgery and the treatment effect of intraoperative dexamethasone. Anaesth Intensive Care. 2024 Jan;52(1):28-36. doi: 10.1177/0310057X231195098. Epub 2023 Nov 24.
- Results publication: PubMed 9631871Taddei S, Virdis A, Ghiadoni L, Magagna A, Salvetti A. Vitamin C improves endothelium-dependent vasodilation by restoring nitric oxide activity in essential hypertension. Circulation. 1998 Jun 9;97(22):2222-9. doi: 10.1161/01.cir.97.22.2222.
- Results publication: PubMed 36004958Muhammad M, Jahangir A, Kassem A, Sattar SBA, Jahangir A, Sahra S, Niazi MRK, Mustafa A, Zia Z, Siddiqui FS, Sadiq W, Mishiyev D, Sammar A, Dahabra L, Irshad A, Elsayegh D, Chalhoub M. The Role and Efficacy of Vitamin C in Sepsis: A Systematic Review and Meta-Analysis. Adv Respir Med. 2022 Jul 28;90(4):281-299. doi: 10.3390/arm90040038.
- Results publication: PubMed 36342116Hill KD, Kannankeril PJ, Jacobs JP, Baldwin HS, Jacobs ML, O'Brien SM, Bichel DP, Graham EM, Blasiole B, Resheidat A, Husain AS, Kumar SR, Kirchner JL, Gallup DS, Turek JW, Bleiweis M, Mettler B, Benscoter A, Wald E, Karamlou T, Van Bergen AH, Overman D, Eghtesady P, Butts R, Kim JS, Scott JP, Anderson BR, Swartz MF, McConnell PI, Vener DF, Li JS; STRESS Network Investigators. Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial. N Engl J Med. 2022 Dec 8;387(23):2138-2149. doi: 10.1056/NEJMoa2212667. Epub 2022 Nov 6.
- Results publication: PubMed 38897349Ott S, Lee ZY, Muller-Wirtz LM, Cangut B, Roessler J, Patterson W, Thomas CM, Bekele BM, Windpassinger M, Lobdell K, Grant MC, Arora RC, Engelman DT, Fremes S, Velten M, O'Brien B, Ruetzler K, Heyland DK, Stoppe C. The effect of a selenium-based anti-inflammatory strategy on postoperative functional recovery in high-risk cardiac surgery patients - A nested sub-study of the sustain CSX trial. Life Sci. 2024 Aug 15;351:122841. doi: 10.1016/j.lfs.2024.122841. Epub 2024 Jun 17.
- Results publication: PubMed 36630120Stoppe C, McDonald B, Meybohm P, Christopher KB, Fremes S, Whitlock R, Mohammadi S, Kalavrouziotis D, Elke G, Rossaint R, Helmer P, Zacharowski K, Gunther U, Parotto M, Niemann B, Boning A, Mazer CD, Jones PM, Ferner M, Lamarche Y, Lamontagne F, Liakopoulos OJ, Cameron M, Muller M, Zarbock A, Wittmann M, Goetzenich A, Kilger E, Schomburg L, Day AG, Heyland DK; SUSTAIN CSX Study Collaborators. Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial. JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.
- Results publication: PubMed 23117776Dieleman JM, Nierich AP, Rosseel PM, van der Maaten JM, Hofland J, Diephuis JC, Schepp RM, Boer C, Moons KG, van Herwerden LA, Tijssen JG, Numan SC, Kalkman CJ, van Dijk D; Dexamethasone for Cardiac Surgery (DECS) Study Group. Intraoperative high-dose dexamethasone for cardiac surgery: a randomized controlled trial. JAMA. 2012 Nov 7;308(17):1761-7. doi: 10.1001/jama.2012.14144.
- Results publication: PubMed 34646018Liu S, Wang Z, Su Y, Qi L, Yang W, Fu M, Jing X, Wang Y, Ma Q. A neuroanatomical basis for electroacupuncture to drive the vagal-adrenal axis. Nature. 2021 Oct;598(7882):641-645. doi: 10.1038/s41586-021-04001-4. Epub 2021 Oct 13.
- Results publication: PubMed 32791039Liu S, Wang ZF, Su YS, Ray RS, Jing XH, Wang YQ, Ma Q. Somatotopic Organization and Intensity Dependence in Driving Distinct NPY-Expressing Sympathetic Pathways by Electroacupuncture. Neuron. 2020 Nov 11;108(3):436-450.e7. doi: 10.1016/j.neuron.2020.07.015. Epub 2020 Aug 12.
- Results publication: PubMed 24562381Torres-Rosas R, Yehia G, Pena G, Mishra P, del Rocio Thompson-Bonilla M, Moreno-Eutimio MA, Arriaga-Pizano LA, Isibasi A, Ulloa L. Dopamine mediates vagal modulation of the immune system by electroacupuncture. Nat Med. 2014 Mar;20(3):291-5. doi: 10.1038/nm.3479. Epub 2014 Feb 23.
- Results publication: PubMed 11825729Paparella D, Yau TM, Young E. Cardiopulmonary bypass induced inflammation: pathophysiology and treatment. An update. Eur J Cardiothorac Surg. 2002 Feb;21(2):232-44. doi: 10.1016/s1010-7940(01)01099-5.
- Results publication: PubMed 22998715Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture at Bilateral ST36 and Acupuncture Without Electrical Stimulation at Bilateral ST36 in people with Systemic Inflammatory Response Syndrome (SIRS) and Cardiac Surgical Procedures, run by Sir Run Run Shaw 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact NI WEI (+8615868153275, 3323158@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-Reactive Protein Level on Postoperative Day 2 (time frame: Postoperative day 2). The study lists 2 primary outcomes in all. 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 NCT07795112, which also lists 13 linked publications.
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 8 Sep 2026.