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

Not Applicable

Completed

• Conditions: Sepsis; Immune Dysfunction
• Interventions: Device: electro-acupuncture

• Registration Number: NCT05367986
• Lead Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2021-02-28
• Study Completion: 2022-01-30
• Study First Submitted: 2022-03-26
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-05
• Last Update Submitted: 2022-05-05
• Study First Posted: 2022-05-10
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electro-acupuncture (EA) group	electro-acupuncture	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.

Primary Outcome Measures

Name	Time	Method
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 .
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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).
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).
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.
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.

Trial Locations

Locations (1)

2nd Affiliated Hospital of Guangzhou University of Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China