Evaluating electroacupuncture for patients with sepsis in the ICU
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
This study is testing whether adding electroacupuncture to standard care can help patients with sepsis in the ICU feel better and recover more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 308 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06666946 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the efficacy and safety of electroacupuncture (EA) when combined with standard ICU therapy for patients diagnosed with sepsis. Conducted at Tongji Hospital, the study will randomly assign eligible participants to either an EA group or a sham EA group, with treatments administered daily for six days. The primary outcome will be measured using the Sequential Organ Failure Assessment (SOFA) score at Day 7, while secondary outcomes will include mortality rates and various organ-support-free days at Day 28. Data will be collected electronically and analyzed to determine the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been diagnosed with sepsis and can provide informed consent.
Not a fit: Patients with lower extremity denervation, severe acute trauma, or those with certain medical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve clinical outcomes and reduce organ dysfunction in sepsis patients receiving ICU care.
How similar studies have performed: While the use of electroacupuncture in critical care settings is less common, preliminary studies suggest potential benefits, though this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Principal investigator: Shusheng Li, PhD. — Tongji Hospital
- Study coordinator: Shusheng Li, PhD.
- Email: lishusheng@hust.edu.cn
- Phone: 86-13971086498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.