Clinical trial NCT05367986: Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
Official title: Lectro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Immune Dysfunction
Keywords: Sepsis
Immune Dysfunction
Electro-acupuncture
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: Patients were randomly divided into an electro-acupuncture (EA) group and a Western medicine group(WM group) using restricted block randomization (1:1 ratio).

Patients in the Western medicine group received conventional treatment with Western medicine. According to the 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 did not include the use of immunosuppressants or immune enhancers including hormones, gamma globulin, and thymosin. 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.

The indicators of immune dysfunction including the percentage of T lymphocyte subsets, percentage of natural killer (NK) cells, and serum soluble programed cell death protein (sPD-1) level, and clinical effect including APACHE-II and SOFA score, whole blood analysis, levels of tumor necrosis factor-α (TNF-α) and C-reactive protein (CRP), were determined before treatment and after treatment for 5 days.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Proportion of T lymphocyte subsets(%)
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Proportion of natural killer(NK) cells(%)
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Level of sPD-1 level(pg/ml)
timeFrame: 5 days after treatment was begun (at the 6th day)
Secondary outcomes:
measure: Neutrophils/Lymphocytes(N/L) ratio(%)
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Level of C-reactive protein (CRP) (mg/L)
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Level of Tumor necrosis factor-α (TNF-α) (pg/ml)
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score
timeFrame: 5 days after treatment was begun (at the 6th day)
measure: Sequential Organ Failure Assessment (SOFA) score
timeFrame: 5 days after treatment was begun (at the 6th day)
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
affiliation: The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
name: Guang Yang
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.