Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients

NCT06666946 | Recruiting DMC

• 2 other identifiers: SEPSIS-ACU(20240730)2022YFC3500704
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

sepsis; electroacupuncture; organ dysfunction; inflammation; immune

Outcome Measures

Primary Outcomes (1)

• Change in the SOFA score between baseline and 7 days after randomization

  The SOFA (Sequential Organ Failure Assessment) score was based on six different scores, one for each of the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems each scored from 0 to 4 with an increasing score reflecting worsening organ dysfunction.

  At baseline (before randomization), and every day after the first treatment to day 7 after randomization

Secondary Outcomes (11)

• All-cause mortality at day 28

  At day 28 after randomization

• All-cause ICU mortality at day 28

  At day 28 after randomization

• ICU-free days to day 28

  At day 28 after randomization

• Hospital-free days to day 28

  At day 28 after randomization

• Ventilator-free time to day 28

  At day 28 after randomization

Other Outcomes (2)

• Serum biomarkers and related cellular assays

  At baseline (before randomization), day 3 and day 7

• Adverse events related to EA or sham EA

  From the beginning of acupuncture , up to 1 hour after the end of each 30 min duration of acupuncture.

Study Arms (2)

EA group

EXPERIMENTAL

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.

Device: Electroacupuncture

Sham EA group

SHAM COMPARATOR

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.

Device: Sham electroacupuncture

Interventions

Electroacupuncture 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.

EA group

Sham electroacupuncture 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.

Sham EA 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 old, and gender is not limited.
• \. 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.
• \. Patients or their legal representatives understand and voluntarily sign the informed consent for this study.

You may not qualify if:

• \. Patients with lower extremity denervation.
• \. Patients with lower extremity amputation or congenital disability with lower limb hypoplasia.
• \. Patients with severe acute trauma such as active bleeding or unfixed fractures in the lower extremities.
• \. Patients with skin damage, infection, bleeding, or hematoma near the lower extremity acupuncture site.
• \. Patients with implantable medical devices, such as pacemakers, implantable cardioverter defibrillators (ICD) or deep brain stimulation (DBS).
• \. Patients who are pregnant, breast feeding during the study.
• \. Patients whose expected duration of ICU length of stay is less than 48 hours.
• \. Patients whose legal representatives refuse routine active treatment and sign palliative treatment consent.
• \. Patients who are currently participating in another randomized clinical trial.
• \. Patients or their legal representatives refused to participate in the study or were unable to sign informed consent.
• \. 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;
• \. Patients with an anticipated survival prognosis of no more than 7 days due to advanced disease.

Sponsors & Collaborators

• Shusheng Li: lead

Study Sites (1)

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

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Sepsis; Inflammation

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Shusheng Li, PhD.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shusheng Li, PhD.

CONTACT

86-13971086498; lishusheng@hust.edu.cn

Yi Bian, Doctor

CONTACT

86-15102710366; bianyi2526@163.com

Study Design

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

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 31, 2024
• Study Start: February 11, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available for two years after the publication of the primary outcomes.

Locations

CN (1)