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

Primary Purpose

Sepsis, Immune Dysfunction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electro-acupuncture
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Immune Dysfunction, Electro-acupuncture

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Western medicine group(WM group)

electro-acupuncture (EA) group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of T lymphocyte subsets(%)
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(%)
Detect proportion of NK cells in total lymphocytes in blood by flow cytometry.
Level of sPD-1 level(pg/ml)
Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA.

Secondary Outcome Measures

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.
Level of C-reactive protein (CRP) (mg/L)
Serum soluble CRP level in blood was measured with ELISA.
Level of Tumor necrosis factor-α (TNF-α) (pg/ml)
Serum soluble TNF-α level in blood was measured with ELISA.
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).
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).

Full Information

First Posted
March 26, 2022
Last Updated
May 5, 2022
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05367986
Brief Title
Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
Acronym
EAIm-sepsis
Official Title
Lectro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
February 28, 2021 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Immune Dysfunction
Keywords
Sepsis, Immune Dysfunction, Electro-acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Western medicine group(WM group)
Arm Type
No Intervention
Arm Description
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.
Arm Title
electro-acupuncture (EA) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electro-acupuncture
Intervention Description
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 Outcome Measure Information:
Title
Proportion of T lymphocyte subsets(%)
Description
Detect proportion of CD3-T lymphocyte and CD4-T lymphocyte(%) in total T lymphocytes in blood by flow cytometry .
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Proportion of natural killer(NK) cells(%)
Description
Detect proportion of NK cells in total lymphocytes in blood by flow cytometry.
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Level of sPD-1 level(pg/ml)
Description
Serum soluble programed cell death protein (sPD-1) level in blood was measured with ELISA.
Time Frame
5 days after treatment was begun (at the 6th day)
Secondary Outcome Measure Information:
Title
Neutrophils/Lymphocytes(N/L) ratio(%)
Description
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.
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Level of C-reactive protein (CRP) (mg/L)
Description
Serum soluble CRP level in blood was measured with ELISA.
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Level of Tumor necrosis factor-α (TNF-α) (pg/ml)
Description
Serum soluble TNF-α level in blood was measured with ELISA.
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Acute Physiology and Chronic Health Evaluation-Ⅱ(APACHE-Ⅱ) score
Description
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).
Time Frame
5 days after treatment was begun (at the 6th day)
Title
Sequential Organ Failure Assessment (SOFA) score
Description
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).
Time Frame
5 days after treatment was begun (at the 6th day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guang Yang
Organizational Affiliation
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
June 1, 2023
IPD Sharing Access Criteria
Doctor or medical researcher Sign relevant confidentiality agreement.
Citations:
PubMed Identifier
31954465
Citation
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.
Results Reference
background
PubMed Identifier
24232462
Citation
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.
Results Reference
background
PubMed Identifier
23036432
Citation
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.
Results Reference
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PubMed Identifier
28101605
Citation
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.
Results Reference
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PubMed Identifier
26825083
Citation
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.
Results Reference
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Electro-acupuncture at Zusanli, Qihai, and Guanyuan Acupoints Regulate Immune Function in Patients With Sepsis

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