Effect of Electroacupuncture on SAP With MODS

Study Overview
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Brief Summary
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Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial Research center: single center Design of the research: A randomized, double-blind and parallel controlled study Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure. Sample size of the research: A total of 220patients,110 cases in each group Interventions: The acupuncture points for electroacupuncture are Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) points . Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at above points once 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 nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output. Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome. Outcome #Primary outcomes: All-cause 28-day mortality. Secondary outcomes: Duration of organ failure; The incidence of pancreatic necrotic tissue infection; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay The estimated duration of the study#2 years.

Detailed Description
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This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) were selected for electroacupuncture treatment, accompanied with evaluating the effects on 28-day mortality in SAP patients with MODS, as well as the duration of organ failure, the incidence of pancreatic necrotic tissue infection and length of hospital stay . To clarify the effect of electroacupuncture on SAP patients with MODS 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 SAP With MODS: a Prospective, Double-blind, Randomized Controlled Trial

Conditions
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Severe Acute Pancreatitis

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 diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset Combine 2 or more organ failures at the same time, and the duration is greater than 48h Age ≥18 years old; Obtain informed consent. Exclusion Criteria: Pregnancy pancreatitis; Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension; Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.). Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion. Those who refuse to participate in the research

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 30 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once 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 Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. AfterDeqi, 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>Participants in the control group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints). 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 nonacupoints (located 1 inch beside acupoints).. 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 |
| --- | --- | --- |
| All-cause 28-day mortality | All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments | 1-2year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of organ failure | The time of organ failure recovered | an average of 1-2 year | 
| The incidence of pancreatic necrotic tissue infection | The incidence of pancreatic necrotic tissue infection | up to one year | 
| Duration of mechanical ventilation in patients with endotracheal intubation in ICU | Duration of mechanical ventilation in patients with endotracheal intubation in ICU | an average of 1 year | 
| Length of stay in hospital | ICU stay time and hospitalization time | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe Acute Pancreatitis, Multiple Organ Disfunction Syndrome