An interventional study of Electroacupuncture and Sham electroacupuncture in Sepsis, sponsored by Shusheng Li. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by Shusheng Li · Not applicable, Interventional, and Treatment
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 308 is above the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Shusheng Li is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: At baseline (before randomization), and every day after the first treatment to day 7 after randomization
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: At day 8 and 9 after randomization
SOFA score of each system
Independent scores for each system that makes up the SOFA score
Time frame: 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
Time frame: 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.
Time frame: At baseline (before randomization), and every day after the first treatment to day 6 after randomization
Serum biomarkers and related cellular assays
TNF-α, IL-6 , IL-1β, IL-8, IL-4 and IL-10 in pg/ml; C-reactive protein (CRP) in mg/L; Procalcitonin (PCT) in ng/ml; Serum soluble programmed cell death protein (sPD-1) levels in pg/ml; Acetylcholine (ACh) in μmol/L; Choline acetyltransferase (ChAT) in μg/L; CD3+ cell fraction, CD4+ cell fraction, CD3+/CD4+ T cell ratio, percentage of NK cells to total lymphocytes, and ratio of neutrophils to lymphocytes (N/L) in percentage.
Time frame: At baseline (before randomization), day 3 and day 7
Adverse events related to EA or sham EA
Outcome assessors will record adverse events after each treatment, including bleeding, subcutaneous haemorrhage, serious pain, and local infection.
Time frame: From the beginning of acupuncture , up to 1 hour after the end of each 30 min duration of acupuncture.
Plan to share: Yes — IPD after de-identification can be shared on individual request to the principal investigator at lishusheng@hust.edu.cn.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: IPD and supporting information will be available for two years after the publication of the primary outcomes.
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Shusheng Li