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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
308
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.
Department of Critical Care Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGChange 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
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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