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NCT Number: NCT05367986

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

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

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Key information

Conditions

Sepsis Immune Dysfunction Immune System Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  • 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.

Primary outcomes

  1. Proportion of T lymphocyte subsets(%)

    Time frame: 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 .

  2. Proportion of natural killer(NK) cells(%)

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

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

  3. Level of sPD-1 level(pg/ml)

    Time frame: 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 outcomes

  1. Neutrophils/Lymphocytes(N/L) ratio(%)

    Time frame: 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.

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

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

    Serum soluble CRP level in blood was measured with ELISA.

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

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

    Serum soluble TNF-α level in blood was measured with ELISA.

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

    Time frame: 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).

  5. Sequential Organ Failure Assessment (SOFA) score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Acronym: EAIm-sepsis

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
May 10, 2022
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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