Immune Dysfunction, Sepsis
Conditions
Keywords
Sepsis, Immune Dysfunction, Electro-acupuncture
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.
Interventions
DEVICEelectro-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. 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.
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of T lymphocyte subsets(%) | 5 days after treatment was begun (at the 6th day) | Detect proportion of CD3-T lymphocyte and CD4-T lymphocyte(%) in total T lymphocytes in blood by flow cytometry . |
| Proportion of natural killer(NK) cells(%) | 5 days after treatment was begun (at the 6th day) | Detect proportion of NK cells in total lymphocytes in blood by flow cytometry. |
| Level of sPD-1 level(pg/ml) | 5 days after treatment was begun (at the 6th day) | Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score | 5 days after treatment was begun (at the 6th day) | 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). |
| Neutrophils/Lymphocytes(N/L) ratio(%) | 5 days after treatment was begun (at the 6th day) | 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. |
| Sequential Organ Failure Assessment (SOFA) score | 5 days after treatment was begun (at the 6th day) | 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). |
| Level of C-reactive protein (CRP) (mg/L) | 5 days after treatment was begun (at the 6th day) | Serum soluble CRP level in blood was measured with ELISA. |
| Level of Tumor necrosis factor-α (TNF-α) (pg/ml) | 5 days after treatment was begun (at the 6th day) | Serum soluble TNF-α level in blood was measured with ELISA. |
Countries
China
Outcome results
None listed