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

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

Detailed Description
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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.

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

Conditions
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Sepsis, Immune Dysfunction

Intervention / Treatment
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* Device: electro-acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Western medicine group(WM group)<br>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. | |
| Experimental: electro-acupuncture (EA) group<br>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<br>* 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. 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. 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophils/Lymphocytes(N/L) ratio(%) | N/L ratio was defined as the ratio of neutrophils to lymphocytes. Whole blood analyzer was used to measure the count neutrophils and lymphocytes in the patient's blood, and calculate the ratio of neutrophil to lymphocyte count. | 5 days after treatment was begun (at the 6th day) | 
| Level of C-reactive protein (CRP) (mg/L) | Serum soluble CRP level in blood was measured with ELISA. | 5 days after treatment was begun (at the 6th day) | 
| Level of Tumor necrosis factor-α (TNF-α) (pg/ml) | Serum soluble TNF-α level in blood was measured with ELISA. | 5 days after treatment was begun (at the 6th day) | 
| Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score | APACHE-Ⅱ score is used to evaluate the severity and prognosis of sepsis patients. Possible score range from 0 (the disease is mild and the prognosis is good) to 71(the disease is serious and the prognosis is poor). | 5 days after treatment was begun (at the 6th day) | 
| Sequential Organ Failure Assessment (SOFA) score | SOFA score is used to evaluate the severity of organ failure. Possible score range from 0 (organ failure is rare and mild) to 48(multiple organ failure, and it's serious). | 5 days after treatment was begun (at the 6th day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Immune Dysfunction, Electro-acupuncture