Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2021-12-22
2023-06-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
electroacupuncture treatment
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. 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.
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.
sham electroacupuncture 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
Interventions
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electroacupuncture treatment
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. 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.
sham electroacupuncture 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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
No
Sponsors
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Jianbo Yu
OTHER
Responsible Party
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Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Central Contacts
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References
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Bakker OJ, van Brunschot S, van Santvoort HC, Besselink MG, Bollen TL, Boermeester MA, Dejong CH, van Goor H, Bosscha K, Ahmed Ali U, Bouwense S, van Grevenstein WM, Heisterkamp J, Houdijk AP, Jansen JM, Karsten TM, Manusama ER, Nieuwenhuijs VB, Schaapherder AF, van der Schelling GP, Schwartz MP, Spanier BW, Tan A, Vecht J, Weusten BL, Witteman BJ, Akkermans LM, Bruno MJ, Dijkgraaf MG, van Ramshorst B, Gooszen HG; Dutch Pancreatitis Study Group. Early versus on-demand nasoenteric tube feeding in acute pancreatitis. N Engl J Med. 2014 Nov 20;371(21):1983-93. doi: 10.1056/NEJMoa1404393.
Kohli P, Gupta V, Kochhar R, Yadav TD, Sinha SK, Lal A. Lavage through percutaneous catheter drains in severe acute pancreatitis: Does it help?A randomized control trial. Pancreatology. 2019 Oct;19(7):929-934. doi: 10.1016/j.pan.2019.09.003. Epub 2019 Sep 9.
Karjula H, Nordblad Schmidt P, Makela J, Liisanantti JH, Ohtonen P, Saarela A. Prophylactic pancreatic duct stenting in severe acute necrotizing pancreatitis: a prospective randomized study. Endoscopy. 2019 Nov;51(11):1027-1034. doi: 10.1055/a-0865-1960. Epub 2019 Mar 20.
Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
Liu Z, Liu Y, Xu H, He L, Chen Y, Fu L, Li N, Lu Y, Su T, Sun J, Wang J, Yue Z, Zhang W, Zhao J, Zhou Z, Wu J, Zhou K, Ai Y, Zhou J, Pang R, Wang Y, Qin Z, Yan S, Li H, Luo L, Liu B. Effect of Electroacupuncture on Urinary Leakage Among Women With Stress Urinary Incontinence: A Randomized Clinical Trial. JAMA. 2017 Jun 27;317(24):2493-2501. doi: 10.1001/jama.2017.7220.
Other Identifiers
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EA-SAP-202103
Identifier Type: -
Identifier Source: org_study_id