Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients

NCT ID: NCT06666946

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2026-08-31

Brief Summary

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.

Detailed 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.

Conditions

Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

EA group

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.

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: DEVICE

Hwato brand disposable acupuncture needles (size 0.30 × 40 mm), and SDZ-V EA apparatuses will be used. Participants in the EA group will receive acupuncture at bilateral ST36 and GB34. After sterilisation, sterile adhesive pads will be placed on bilateral ST36 and GB34, and acupuncture needles will be inserted through the adhesive pads approximately 20 to 30 mm into the skin. Following needle insertion, manual manipulation of needles will be performed on all needles to reach de qi (a composite of sensations including soreness, numbness, distention, heaviness, and other sensations). Then, paired electrodes from the EA apparatus will be attached transversely to the needle handles at bilateral ST36 and GB34. EA stimulation lasted for 30 minutes with a continuous wave of 10 Hz and a current intensity of 0.5 to 1 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive 6 treatment sessions once daily for 6 consecutive days.

Sham EA group

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.

Group Type: SHAM_COMPARATOR

Sham electroacupuncture

Intervention Type: DEVICE

Non-insertive placebo needles (size 0.30 × 30 mm), and SDZ-V EA apparatuses will be used. Participants in the sham EA group will receive sham EA with a non-insertive placebo needle on sham acupoints. The sham ST36 point is located at 1 cun (≈20 mm) lateral to ST36, and the sham GB34 point is located at 1 cun (≈20mm) lateral to GB 34. Procedures, electrode placements, and other treatment settings will be the same as in the EA group but with no skin penetration, electricity output, or de qi.

Interventions

Electroacupuncture

Hwato brand disposable acupuncture needles (size 0.30 × 40 mm), and SDZ-V EA apparatuses will be used. Participants in the EA group will receive acupuncture at bilateral ST36 and GB34. After sterilisation, sterile adhesive pads will be placed on bilateral ST36 and GB34, and acupuncture needles will be inserted through the adhesive pads approximately 20 to 30 mm into the skin. Following needle insertion, manual manipulation of needles will be performed on all needles to reach de qi (a composite of sensations including soreness, numbness, distention, heaviness, and other sensations). Then, paired electrodes from the EA apparatus will be attached transversely to the needle handles at bilateral ST36 and GB34. EA stimulation lasted for 30 minutes with a continuous wave of 10 Hz and a current intensity of 0.5 to 1 mA (preferably with the skin around the acupoints shivering mildly without pain). Participants will receive 6 treatment sessions once daily for 6 consecutive days.

Intervention Type: DEVICE

Sham electroacupuncture

Non-insertive placebo needles (size 0.30 × 30 mm), and SDZ-V EA apparatuses will be used. Participants in the sham EA group will receive sham EA with a non-insertive placebo needle on sham acupoints. The sham ST36 point is located at 1 cun (≈20 mm) lateral to ST36, and the sham GB34 point is located at 1 cun (≈20mm) lateral to GB 34. Procedures, electrode placements, and other treatment settings will be the same as in the EA group but with no skin penetration, electricity output, or de qi.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shusheng Li

OTHER

Sponsor Role: lead

Responsible Party

Shusheng Li

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shusheng Li, PhD.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shusheng Li, PhD.

Role: CONTACT

lishusheng@hust.edu.cn

86-13971086498

Yi Bian, Doctor

Role: CONTACT

bianyi2526@163.com

86-15102710366

Facility Contacts

Shusheng Li, PhD.

Role: primary

lishusheng@hust.edu.cn

86-13971086498

Yi Bian, Doctor

Role: backup

bianyi2526@163.com

86-15102710366

Other Identifiers

2022YFC3500704

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SEPSIS-ACU(20240730)

Identifier Type: -

Identifier Source: org_study_id