Electroacupuncture at ST36 for Reducing Postoperative Inflammation After Cardiac Surgery With Cardiopulmonary Bypass

NCT07795112 | Recruiting DMC

• 2 other identifiers: SRRSH2026-0762MR-33-26-061297
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 ICU stay, an average of 2 days.

• Systemic Inflammatory Response Syndrome Score

  Postoperative day 2

• Duration of Mechanical Ventilation

  From postoperative ICU admission until final successful extubation, an average of 2 days.

• Intensive Care Unit Length of Stay

  From postoperative ICU admission until ICU discharge, an average of 4 days

• Hospital Length of Stay

  From postoperative ICU admission until hospital discharge, an average of 14 days

Study Arms (2)

Electroacupuncture Group

EXPERIMENTAL

Other: Electroacupuncture at Bilateral ST36

Acupuncture Without Electrical Stimulation Group

SHAM COMPARATOR

Other: Acupuncture Without Electrical Stimulation at Bilateral ST36

Interventions

Electroacupuncture at Bilateral ST36 OTHER

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.

Electroacupuncture Group

Acupuncture Without Electrical Stimulation at Bilateral ST36 OTHER

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.

Acupuncture Without Electrical Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (13)

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MeSH Terms

Conditions

Systemic Inflammatory Response Syndrome; Postoperative Complications

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

NI WEI

CONTACT

+8615868153275; 3323158@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 31, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 8, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)