Effect of Electroacupuncture on SAP With MODS

NCT04813510 | Unknown

• 1 other identifier: EA-SAP-202103
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial
2. 2.Research center: single center
3. 3.Design of the research: A randomized, double-blind and parallel controlled study
4. 4.Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.
5. 5.Sample size of the research: A total of 220patients,110 cases in each group
6. 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. 7.Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.
8. 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. 9.The estimated duration of the study#2 years.

Conditions

Severe Acute Pancreatitis

Keywords

Severe Acute Pancreatitis; Multiple Organ Disfunction Syndrome

Outcome Measures

Primary Outcomes (1)

• All-cause 28-day mortality

  All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments

  1-2year

Secondary Outcomes (4)

• Duration of organ failure

  an average of 1-2 year

• The incidence of pancreatic necrotic tissue infection

  up to one year

• Duration of mechanical ventilation in patients with endotracheal intubation in ICU

  an average of 1 year

• Length of stay in hospital

  24 months

Study Arms (2)

electroacupuncture treatment

EXPERIMENTAL

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.

Device: electroacupuncture treatment

sham electroacupuncture treatment

SHAM COMPARATOR

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

Interventions

electroacupuncture treatment DEVICE

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.

electroacupuncture treatment

sham electroacupuncture treatment DEVICE

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

sham electroacupuncture treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jianbo Yu: lead

Related Publications (5)

• 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.

  PMID: 25409371 BACKGROUND

• 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.

  PMID: 31521496 BACKGROUND

• 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.

  PMID: 30895583 BACKGROUND

• 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.

  PMID: 27618593 BACKGROUND

• 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.

  PMID: 28655016 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Yingya Cao, MD

CONTACT

15055324662; caoyingya1990@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: December 22, 2021
• Primary Completion: December 31, 2022
• Study Completion: June 30, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-12