Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis

NCT05367986 | Completed DMC

• 1 other identifier: EAIm-sepsis
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the biochemical and clinical effects of electro-acupuncture in patients with sepsis.

Conditions

Sepsis; Immune Dysfunction

Keywords

Sepsis; Immune Dysfunction; Electro-acupuncture

Outcome Measures

Primary Outcomes (3)

• Proportion of T lymphocyte subsets(%)

  Detect proportion of CD3-T lymphocyte and CD4-T lymphocyte(%) in total T lymphocytes in blood by flow cytometry .

  5 days after treatment was begun (at the 6th day)

• Proportion of natural killer(NK) cells(%)

  Detect proportion of NK cells in total lymphocytes in blood by flow cytometry.

  5 days after treatment was begun (at the 6th day)

• Level of sPD-1 level(pg/ml)

  Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA.

  5 days after treatment was begun (at the 6th day)

Secondary Outcomes (5)

• Neutrophils/Lymphocytes(N/L) ratio(%)

  5 days after treatment was begun (at the 6th day)

• Level of C-reactive protein (CRP) (mg/L)

  5 days after treatment was begun (at the 6th day)

• Level of Tumor necrosis factor-α (TNF-α) (pg/ml)

  5 days after treatment was begun (at the 6th day)

• Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score

  5 days after treatment was begun (at the 6th day)

• Sequential Organ Failure Assessment (SOFA) score

  5 days after treatment was begun (at the 6th day)

Study Arms (2)

Western medicine group(WM group)

NO INTERVENTION

Patients in the Western medicine group received conventional treatment with Western medicine. According to International Guidelines for Management of Sepsis and Septic Shock: 2016, conventional treatment includes antibiotics and other anti-infection measures, fluid management, mechanical ventilation, and nutritional support, but does not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin.

electro-acupuncture (EA) group

EXPERIMENTAL

Patients in the electro-acupuncture group were treated with Western medicine and electro-acupuncture. Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total.

Device: electro-acupuncture

Interventions

electro-acupuncture DEVICE

Electro-acupuncture was given at the Zusanli (ST36), Guanyuan (CV4), and Qihai (CV6) acupoints, twice a day for 30 minutes, and for 5 days in total. 1. Acupoints were selected as follows. (1) Zusanli (ST36) belongs to zuyangming stomach meridian. It is located on the anterolateral part of the lower leg 3 inches (4 horizontal fingers) below the eye of the external knee between the fibula and the tibia, and a horizontal finger (middle finger) width from the front edge of the tibia. (2) Guan yuan (CV4) is located 3 inches below the umbilicus, on the midline of the abdomen. (3) Qihai (CV6) is located 1.5 inches below the umbilicus on the midline. 2. Acupuncture and electro-acupuncture methods were performed as follows. Participants were in the supine position, and needles was inserted in the skin . After the participant has acid, numbness, swelling, pain or other feelings, the electro-acupuncture device was connect to the acupuncture needle, the frequency was set to continuous wave.

electro-acupuncture (EA) group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of sepsis;
• Signed the informed consent form.

You may not qualify if:

• Pregnancy or psychiatric disorder;
• Immune deficiency or using immunosuppressants or immune enhancers;
• History of malignancy;
• HIV positive;
• Unwilling to participate in the study or cooperate with the treatment. Patients who cannot tolerate electroacupuncture treatment or loss of follow-up for complicating with other diseases during the study would be dropped off.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Related Publications (5)

• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

  PMID: 31954465 BACKGROUND

• Hotchkiss RS, Monneret G, Payen D. Sepsis-induced immunosuppression: from cellular dysfunctions to immunotherapy. Nat Rev Immunol. 2013 Dec;13(12):862-74. doi: 10.1038/nri3552. Epub 2013 Nov 15.

  PMID: 24232462 BACKGROUND

• Bosmann M, Ward PA. The inflammatory response in sepsis. Trends Immunol. 2013 Mar;34(3):129-36. doi: 10.1016/j.it.2012.09.004. Epub 2012 Oct 2.

  PMID: 23036432 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18.

  PMID: 28101605 BACKGROUND

• Yang G, Hu RY, Deng AJ, Huang Y, Li J. Effects of Electro-Acupuncture at Zusanli, Guanyuan for Sepsis Patients and Its Mechanism through Immune Regulation. Chin J Integr Med. 2016 Mar;22(3):219-24. doi: 10.1007/s11655-016-2462-9. Epub 2016 Jan 29.

  PMID: 26825083 BACKGROUND

MeSH Terms

Conditions

Sepsis; Immune System Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guang Yang

  The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 26, 2022
• First Posted: May 10, 2022
• Study Start: July 1, 2019
• Primary Completion: February 28, 2021
• Study Completion: January 30, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: June 1, 2023
• Access Criteria: 1. Doctor or medical researcher 2. Sign relevant confidentiality agreement.

Locations

CN (1)