Clinical trial NCT06666946: Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Keywords: sepsis
electroacupuncture
organ dysfunction
inflammation
immune
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in the SOFA score between baseline and 7 days after randomization
timeFrame: At baseline (before randomization), and every day after the first treatment to day 7 after randomization
Secondary outcomes:
measure: All-cause mortality at day 28
timeFrame: At day 28 after randomization
measure: All-cause ICU mortality at day 28
timeFrame: At day 28 after randomization
measure: ICU-free days to day 28
timeFrame: At day 28 after randomization
measure: Hospital-free days to day 28
timeFrame: At day 28 after randomization
measure: Ventilator-free time to day 28
timeFrame: At day 28 after randomization
measure: Vasopressor-free days to day 28
timeFrame: At day 28 after randomization
measure: CRRT-free days to day 28
timeFrame: At day 28 after randomization
measure: SOFA score at Day 8 and 9 after randomization
timeFrame: At day 8 and 9 after randomization
measure: SOFA score of each system
timeFrame: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
measure: SOFA score components
timeFrame: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
measure: Liquid equilibrium parameter
timeFrame: At baseline (before randomization), and every day after the first treatment to day 6 after randomization
Other outcomes:
measure: Serum biomarkers and related cellular assays
timeFrame: At baseline (before randomization), day 3 and day 7
measure: Adverse events related to EA or sham EA
timeFrame: From the beginning of acupuncture , up to 1 hour after the end of each 30 min duration of acupuncture.
Locations:
city: Wuhan
country: China
facility: Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Shusheng Li, PhD.
role: PRINCIPAL_INVESTIGATOR
References: