Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

Study Overview
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Brief Summary
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Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction Research center: single center The Design of the study: Randomized, double-blind, controlled study The population of the study: The patients over 18 years that met the criteria of sepsis3.0 and with AGI grade II or above are enrolled in the study Sample size: Enroll 60 patients (30patients in each group) Interventions: Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. AfterDeqi,electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment. Participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output. The aim of the research: To investigate the effect of electroacupuncture on sepsis-induced intestinal dysfunction. Outcome# 1) Primary outcome: The intestinal function indicators including: 1) Clinical symptoms: bowel sounds, intra-abdominal pressure, time to first exhaust/defecation, daily tolerable enteral nutrition 2) Intestinal motility indicators: the levels of serum motilin and gastrin 3) Intestinal barrier indicators: the levels of serum diamine oxidase (DAO), D-lactic acid and I-FABP 2)Secondary outcome# Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital; 30-day life quality and cognitive function after surgery; All-cause 28-day mortality. The estimated duration of the study#1-2years.

Detailed Description
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This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, ST36 (Zusanli) and ST37 (Shangjuxu) were selected for electroacupuncture treatment, accompanied with evaluating the effects on intestinal function in septic patients. Meanwhile, the blood biochemical indexes such as heme oxygenase-1(HO-1), PTEN induced putative kinase 1(PINK1), polo-like kinase 1(PLK1) and interleukin-6 are detected. To clarify the effect of electroacupuncture on sepsis-induced intestinal dysfunction is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

Official Title
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Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction: a Prospective, Double-blind, Randomized Controlled Trial

Conditions
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Sepsis, Intestinal Dysfunction

Intervention / Treatment
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* Device: electroacupuncture treatment
* Device: sham electroacupuncture treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet the diagnostic criteria of sepsis 3.0 AGI grade II or above, At least 18 years old Volunteer to participate in this study and sign the informed consent form Exclusion Criteria: Patients with bowel dysfunction caused by other diseases or surgical operations Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis Those who have recently used gastrointestinal motility drugs and within 5 times the half-life Those who are participating in other drug clinical trials Refuse to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroacupuncture treatment<br>Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. AfterDeqi,electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment | Device: electroacupuncture treatment<br>* Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days.After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1   30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.<br>|
| Sham Comparator: sham electroacupuncture treatment<br>sham electroacupuncture treatment participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output. | Device: sham electroacupuncture treatment<br>* Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output, and retained the needle for the same time as treatment group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect on intestinal motility | Record the serum levels of motilin of the two groups | an average of one year | 
| The effect on intestinal motility | Record the serum levels of gastrin of the two groups | an average of 1 year | 
| The effect on intestinal barrier | Record serum levels of DAO of the two groups | up to 1 year | 
| The effect on intestinal barrier | Record serum levels of I-FABP of the two groups | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation in patients with endotracheal intubation in ICU | Duration of mechanical ventilation and endotracheal intubation in ICU | one year | 
| Length of stay in hospital | ICU stay time and hospitalization time | up to one year | 
| All-cause 28-day mortality | All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, electroacupuncture, intestinal dysfunction