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Electroacupuncture at ST36 for Reducing Postoperative Inflammation After Cardiac Surgery With Cardiopulmonary Bypass
Condition(s) studied
Systemic Inflammatory Response Syndrome (SIRS)Cardiac Surgical ProceduresPostoperative Complications (Cardiopulmonary)
Investigational drug(s) / intervention(s)
Electroacupuncture at Bilateral ST36Acupuncture Without Electrical Stimulation at Bilateral ST36
Electroacupuncture at Bilateral ST36: 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 ST36: 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 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 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.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Primary outcome measure(s)
- C-Reactive Protein Level on Postoperative Day 2 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine |
Hangzhou |
Zhejiang |
Recruiting |
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