Cardiac Surgical Procedures, Postoperative Complications (Cardiopulmonary), Systemic Inflammatory Response Syndrome (SIRS)
Conditions
Keywords
Electroacupuncture, Zusanli, ST36, Cardiopulmonary Bypass, Postoperative Inflammation, Sequential Organ Failure Assessment, Systemic Inflammatory Response Syndrome
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.
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.
Interventions
OTHERElectroacupuncture 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.
OTHERAcupuncture 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.
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Systemic Inflammatory Response Syndrome Score | Postoperative day 2 | 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. |
| Duration of Mechanical Ventilation | From postoperative ICU admission until final successful extubation, an average of 2 days. | 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. |
| Intensive Care Unit Length of Stay | From postoperative ICU admission until ICU discharge, an average of 4 days | 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. |
| Hospital Length of Stay | From postoperative ICU admission until hospital discharge, an average of 14 days | 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 |
Countries
China
Contacts
CONTACTNI WEI
Outcome results
None listed