RecruitingNot ApplicableNCT06666946

Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients

Efficacy and Safety Study of Early Electroacupuncture Treatment Combined With ICU Standard Therapy on Organ Dysfunction and Clinical Outcomes in Patients With Sepsis: a Single-center, Randomized, Sham-Controlled Trial

Sponsor

Shusheng Li

Enrollment

308 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Sepsis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria3

\. 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.

Exclusion Criteria12

\. 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.

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Interventions

DEVICEElectroacupuncture

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.

DEVICESham 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.