Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients (SEPSIS-ACU)

Shusheng Li

Status: Enrolling

Conditions: Sepsis

Treatments: Device: Electroacupuncture; Device: Sham electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06666946

SEPSIS-ACU(20240730)

2022YFC3500704 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) combined with standard Intensive Care Unit (ICU) therapy on organ dysfunction and other clinical outcomes in sepsis patients. Additionally, this study will conduct subgroup analyses to investigate the influence of septic shock and immunomodulators on the treatment effects and their correlation with electroacupuncture efficacy.

Full description

The proposed single-center, participant-blind, two arms, randomized, sham-controlled clinical trial is to evaluate the efficacy and safety of electroacupuncture (EA) combined with standard Intensive Care Unit (ICU) therapy on organ dysfunction and other clinical outcomes in sepsis patients. We planned to conduct this single-center trial in Tongji Hospital, affiliated to Huazhong University of Science and Technology (HUST). Patients, who are initially diagnosed with sepsis, will be assessed for eligibility within 24 hours of their ICU admission. Then, eligible participants will be informed and randomly assigned to one of the two groups: the EA group or the sham EA group, in a 1:1 ratio using block randomization. Patients will receive the first EA/sham EA therapy within 24 hours after randomization. The treatment will be administered once daily for 6 days continuously, and followed by 28 days after randomization. The primary outcome will be the SOFA score at Day 7 after randomization. Secondary outcomes include mortality, ICU-free days, hospital-free days, organ-support-free days at Day 28. SOFA score components and related serological results will also be included. Data collection will be conducted by an electronic data management system. Data analyses will be performed on a full analysis set and a per protocol set.

Enrollment: 308 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Age ≥ 18 years old, and gender is not limited.
• 2. Meets the diagnostic criteria of Sepsis (Sepsis-3): In patients with infection or suspected infection, Sepsis is diagnosed when the Sequential (Sepsis related) Organ Failure Assessment (SOFA) score increased by ≥2 points from baseline.
• 3. Patients or their legal representatives understand and voluntarily sign the informed consent for this study.

Exclusion criteria

• 1. Patients with lower extremity denervation.
• 2. Patients with lower extremity amputation or congenital disability with lower limb hypoplasia.
• 3. Patients with severe acute trauma such as active bleeding or unfixed fractures in the lower extremities.
• 4. Patients with skin damage, infection, bleeding, or hematoma near the lower extremity acupuncture site.
• 5. Patients with implantable medical devices, such as pacemakers, implantable cardioverter defibrillators (ICD) or deep brain stimulation (DBS).
• 6. Patients who are pregnant, breast feeding during the study.
• 7. Patients whose expected duration of ICU length of stay is less than 48 hours.
• 8. Patients whose legal representatives refuse routine active treatment and sign palliative treatment consent.
• 9. Patients who are currently participating in another randomized clinical trial.
• 10. Patients or their legal representatives refused to participate in the study or were unable to sign informed consent.
• 11. Immunosuppressive status, including but not limited to: congenital immunosuppressive patients, AIDS patients, organ transplant patients, long-term use of immunosuppressive patients, patients receiving tumor radiotherapy or chemotherapy within 1 month;
• 12. Patients with an anticipated survival prognosis of no more than 7 days due to advanced disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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308 participants in 2 patient groups

EA group

Experimental group

Description:

For the EA group, participants will be assigned to receive 6 sessions of EA applied at bilateral acupoints Zusanli (ST36) and Yanglingquan (GB34), once daily, with the first session of EA applied within 24 hours after randomization.

Treatment:

Device: Electroacupuncture

Sham EA group

Sham Comparator group

Description:

For the sham EA group, participants will be assigned to receive 6 sessions of sham EA on two sham points, once daily, with the first session of sham EA applied within 24 hours after randomization.

Treatment:

Device: Sham electroacupuncture