SepsisSEPSIS-ACUNCT06666946
Efficacy and Safety of Electroacupuncture for ICU Sepsis Patients
A study testing Electroacupuncture in people with Sepsis, run by Shusheng Li at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Shusheng Li, PhD., 86-13971086498, lishusheng@hust.edu.cn
Yi Bian, Doctor, 86-15102710366, bianyi2526@163.com
About this study
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
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.
Read the 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
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- sepsis, electroacupuncture, organ dysfunction, inflammation, immune
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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 electroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
It refers to the total number of patients who die from any cause within 28 days of being admitted to the hospital. It will be described as a ratio.
Measured: At day 28 after randomization
All-cause ICU mortality at day 28
It refers to the total number of patients who die in the ICU from any cause within 28 days of being admitted to the hospital. It will be described as a ratio.
Measured: At day 28 after randomization
ICU-free days to day 28
The number of days from the patient's discharge from the ICU to the 28th day after randomization is calculated. If the patient re-enters the ICU, the total number of days without ICU care is subtracted from the number of days spent in the ICU.
Measured: At day 28 after randomization
Hospital-free days to day 28
The number of days from the patient's discharge to the 28th day after randomization is calculated. If the patient re-enters the hospital, the total number of days without hospital care is subtracted from the number of days spent in the hospital.
Measured: At day 28 after randomization
Ventilator-free time to day 28
This refers to the period from randomization to the 28th day, during which the patient must be alive and have at least 48 hours off the ventilator. Subtract the time that the ventilator was required again from the total time. If the patient dies in the hospital after being off the ventilator, the value is set to 0.
Measured: At day 28 after randomization
Vasopressor-free days to day 28
From randomization to the 28th day, this refers to the time the patient is alive and has not received vasopressor medications for at least 4 hours. If the patient dies in the hospital after discontinuing the medication, the value is set to 0.
Measured: At day 28 after randomization
CRRT-free days to day 28
The time from randomization to the 28th day during which the patient did not use continuous renal replacement therapy(CRRT).
Measured: At day 28 after randomization
SOFA score at Day 8 and 9 after randomization
After-effect assessed by SOFA score, which is same as the description of the primary outcome.
Measured: At day 8 and 9 after randomization
SOFA score of each system
Independent scores for each system that makes up the SOFA score
Measured: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
SOFA score components
ie, PaO2 to FiO2 ratio, ventilator use, platelet counts, total bilirubin, MAP, vasopressor use, creatinine level, urine volume
Measured: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
Liquid equilibrium parameter
Daily fluid intake, output and fluid balance of ICU patients will be recorded continuously.
Measured: At baseline (before randomization), and every day after the first treatment to day 6 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start11 Feb 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shusheng Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shusheng Li, Tongji Hospital
- Investigators
- Shusheng Li, PhD., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666946
- Sponsor's protocol ID
- SEPSIS-ACU(20240730)
- Other IDs
- 2022YFC3500704
- Acronym
- SEPSIS-ACU
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
Publications
Meng Q, Yu LL, Jing XH, Li M, Huang QR, Xu TT, Bian Y, Li SS. Electroacupuncture as Adjunctive Therapy for Organ Dysfunction Among Chinese ICU Patients with Sepsis: Study Protocol for a Randomized Clinical Trial. Curr Med Sci. 2026 Jul 23. doi: 10.1007/s11596-026-00225-5. Online ahead of print.
PubMed 42490017
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06666946
- Acronym / sponsor ID
- SEPSIS-ACU / SEPSIS-ACU(20240730)
- Conditions
- Sepsis
- Keywords
- sepsis, electroacupuncture, organ dysfunction, inflammation, immune
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Shusheng LiUniversity, hospital or other
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA group | Experimental | Device: ElectroacupunctureFor 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. |
| Sham EA group | Sham comparator | Device: Sham electroacupunctureFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureHwato 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. | Device | EA group |
| Sham electroacupunctureNon-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. | Device | Sham EA group |
Primary outcome
Change in the SOFA score between baseline and 7 days after randomization
Time frame: At baseline (before randomization), and every day after the first treatment to day 7 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.
11 secondary outcomes
All-cause mortality at day 28
Time frame: At day 28 after randomization
All-cause ICU mortality at day 28
Time frame: At day 28 after randomization
ICU-free days to day 28
Time frame: At day 28 after randomization
Hospital-free days to day 28
Time frame: At day 28 after randomization
Ventilator-free time to day 28
Time frame: At day 28 after randomization
Vasopressor-free days to day 28
Time frame: At day 28 after randomization
CRRT-free days to day 28
Time frame: At day 28 after randomization
SOFA score at Day 8 and 9 after randomization
Time frame: At day 8 and 9 after randomization
SOFA score of each system
Time frame: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
SOFA score components
Time frame: At baseline (before randomization), and every day after the first treatment to day 9 after randomization
Liquid equilibrium parameter
Time frame: At baseline (before randomization), and every day after the first treatment to day 6 after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Derived from this study: PubMed 42490017Meng Q, Yu LL, Jing XH, Li M, Huang QR, Xu TT, Bian Y, Li SS. Electroacupuncture as Adjunctive Therapy for Organ Dysfunction Among Chinese ICU Patients with Sepsis: Study Protocol for a Randomized Clinical Trial. Curr Med Sci. 2026 Jul 23. doi: 10.1007/s11596-026-00225-5. Online ahead of print.
- Individual participant dataSharing planned: Yes. IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shusheng Li, PhD. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Sepsis, run by Shusheng Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shusheng Li, PhD. (86-13971086498, lishusheng@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the SOFA score between baseline and 7 days after randomization (time frame: At baseline (before randomization), and every day after the first treatment to day 7 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06666946, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.