Clinical trial NCT04813510: Effect of Electroacupuncture on SAP With MODS
Official title: Effect of Electroacupuncture on SAP With MODS: a Prospective, Double-blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Acute Pancreatitis
Keywords: Severe Acute Pancreatitis
Multiple Organ Disfunction Syndrome
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-cause 28-day mortality
timeFrame: 1-2year
Secondary outcomes:
measure: Duration of organ failure
timeFrame: an average of 1-2 year
measure: The incidence of pancreatic necrotic tissue infection
timeFrame: up to one year
measure: Duration of mechanical ventilation in patients with endotracheal intubation in ICU
timeFrame: an average of 1 year
measure: Length of stay in hospital
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
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