Severe Acute Pancreatitis
Conditions
Keywords
Severe Acute Pancreatitis, Multiple Organ Disfunction Syndrome
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. 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. 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.
Interventions
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.
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
Sponsors
Jianbo Yu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause 28-day mortality | 1-2year | All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of organ failure | an average of 1-2 year | The time of organ failure recovered |
| The incidence of pancreatic necrotic tissue infection | up to one year | The incidence of pancreatic necrotic tissue infection |
| 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 |
| Length of stay in hospital | 24 months | ICU stay time and hospitalization time |
Contacts
Primary ContactYingya Cao, MD
Outcome results
None listed