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SepsisEAIm-sepsisNCT05367986

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

A study testing electro-acupuncture in people with Sepsis and Immune Dysfunction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Sepsis, Immune Dysfunction
What is being tested?
electro-acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
1 Jul 2019to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Lectro-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.

Read the 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.

Being tested
electro-acupuncture
Keywords
Sepsis, Immune Dysfunction, Electro-acupuncture
Medical subject headings
Sepsis, Immune System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electro-acupunctureDevice

    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.
Study groups in NCT05367986
Study groupRoleWhat they receive
Western medicine group(WM group)No interventionPatients 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.
electro-acupuncture (EA) groupExperimentalPatients 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.
Receives: Device: electro-acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of T lymphocyte subsets(%)

    Detect proportion of CD3-T lymphocyte and CD4-T lymphocyte(%) in total T lymphocytes in blood by flow cytometry .

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

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

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

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

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

    Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA.

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

Secondary outcomes (5)

  1. 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.

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

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

    Serum soluble CRP level in blood was measured with ELISA.

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

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

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

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

  4. 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).

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

  5. 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start1 Jul 2019
  3. Primary completion28 Feb 2021
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367986
Sponsor's protocol ID
EAIm-sepsis
Acronym
EAIm-sepsis
Status last verified
May 2022
First submitted
26 Mar 2022
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data that support the findings of this study are available on request from the corrresponding author.The data are not publicly available due to privacy or ethical restrictions.The data that supprot the findings of this study are available from the corresponding author upon reasonable request.

Publications

  • 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.

    PubMed 31954465

  • 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.

    PubMed 24232462

  • 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.

    PubMed 23036432

  • 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.

    PubMed 28101605

  • 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.

    PubMed 26825083

Questions about this trial

What is this clinical trial studying?

A study testing electro-acupuncture in people with Sepsis and Immune Dysfunction, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of T lymphocyte subsets(%) (time frame: 5 days after treatment was begun (at the 6th day)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367986, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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EAIm-sepsis Clinical Trial NCT05367986 | AzTrials