An interventional study of Electroacupuncture at Bilateral ST36 and Acupuncture Without Electrical Stimulation at Bilateral ST36 in Systemic Inflammatory Response Syndrome (SIRS), Cardiac Surgical Procedures and Postoperative Complications (Cardiopulmonary), sponsored by Sir Run Run Shaw Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Sir Run Run Shaw Hospital · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Other: Electroacupuncture at Bilateral ST36
Other: Acupuncture Without Electrical Stimulation 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.
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.
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.
Time frame: 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.
Time frame: Postoperative day 2
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From postoperative ICU admission until hospital discharge, an average of 14 days
Plan to share: No
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Sir Run Run Shaw Hospital