Effect of Electroacupuncture on SAP With MODS

Not Applicable

• Conditions: Severe Acute Pancreatitis
• Interventions: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

• Registration Number: NCT04813510
• Lead Sponsor: Jianbo Yu

Brief Summary

1. Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial

2. Research center: single center

3. Design of the research: A randomized, double-blind and parallel controlled study

4. Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.

5. Sample size of the research: A total of 220patients,110 cases in each group

6. 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. After"Deqi",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.

7. Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.

8. 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

9. The estimated duration of the study#2 years.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-21
• Study Start: 2021-12-22
• Last Update Posted: 2021-12-22
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Meet the diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset
2. Combine 2 or more organ failures at the same time, and the duration is greater than 48h
3. Age ≥18 years old;
4. Obtain informed consent.

Exclusion Criteria

1. Pregnancy pancreatitis;
2. Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension;
3. Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.).
4. Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion.
5. Those who refuse to participate in the research

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroacupuncture treatment	electroacupuncture treatment	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. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment.
sham electroacupuncture treatment	sham electroacupuncture 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.

Primary Outcome Measures

Name	Time	Method
All-cause 28-day mortality	1-2year	All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments

Secondary Outcome Measures

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