Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction
NCT ID: NCT04646629
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-11-23
2022-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
2. Research center: single center
3. The Design of the study: Randomized, double-blind, controlled study
4. The population of the study: The patients over 18 years that met the criteria of sepsis3.0 and with AGI grade II or above are enrolled in the study
5. Sample size: Enroll 60 patients (30patients in each group)
6. Interventions: Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected and maintained the end of treatment.
Participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
7. The aim of the research: To investigate the effect of electroacupuncture on sepsis-induced intestinal dysfunction.
8. Outcome# 1) Primary outcome: The intestinal function indicators including: 1) Clinical symptoms: bowel sounds, intra-abdominal pressure, time to first exhaust/defecation, daily tolerable enteral nutrition 2) Intestinal motility indicators: the levels of serum motilin and gastrin 3) Intestinal barrier indicators: the levels of serum diamine oxidase (DAO), D-lactic acid and I-FABP 2)Secondary outcome# Duration of mechanical ventilation in patients with endotracheal intubation on ICU admission; Length of stay in ICU and Length of stay in hospital; 30-day life quality and cognitive function after surgery; All-cause 28-day mortality.
9. The estimated duration of the study#1-2years.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
electroacupuncture treatment
Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days. After"Deqi",electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) isconnected and maintained the end of treatment
electroacupuncture treatment
Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days.After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 \~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.
sham electroacupuncture treatment
sham electroacupuncture treatment participants in the control group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
sham electroacupuncture treatment
Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output, and retained the needle for the same time as treatment group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
electroacupuncture treatment
Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days.After "Deqi", electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 \~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment.
sham electroacupuncture treatment
Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output, and retained the needle for the same time as treatment group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. AGI grade II or above,
3. At least 18 years old
4. Volunteer to participate in this study and sign the informed consent form
Exclusion Criteria
2. Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
3. Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
4. Those who are participating in other drug clinical trials
5. Refuse to participate in this study
18 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Jianbo Yu
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jianbo Yu, PhD
Role: STUDY_CHAIR
Tianjin Nankai Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Electroacupuncture Apparatus
Tianjin, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yingya Cao, MD
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Meng JB, Jiao YN, Zhang G, Xu XJ, Ji CL, Hu MH, Lai ZZ, Zhang M. Electroacupuncture Improves Intestinal Dysfunction in Septic Patients: A Randomised Controlled Trial. Biomed Res Int. 2018 Jun 26;2018:8293594. doi: 10.1155/2018/8293594. eCollection 2018.
Yoseph BP, Klingensmith NJ, Liang Z, Breed ER, Burd EM, Mittal R, Dominguez JA, Petrie B, Ford ML, Coopersmith CM. Mechanisms of Intestinal Barrier Dysfunction in Sepsis. Shock. 2016 Jul;46(1):52-9. doi: 10.1097/SHK.0000000000000565.
Li HF, Hu GQ, Liu WW. [Clinical trials of acupuncture of Jiaji (EX-B2) for treatment of gastrointestinal dysfunction in sepsis patients]. Zhen Ci Yan Jiu. 2019 Jan 25;44(1):43-6. doi: 10.13702/j.1000-0607.170579. Chinese.
Liu H, Zhu J, Ni HB, Hu XX. [Transcutaneous electrical acupoint stimulation for early enteral nutrition tolerance in patients with sepsis of gastrointestinal dysfunction: a multi-center randomized controlled trial]. Zhongguo Zhen Jiu. 2020 Mar 12;40(3):229-33. doi: 10.13703/j.0255-2930.20190426-0003. Chinese.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NKYY_YXKT_IRB_2020_071_01
Identifier Type: -
Identifier Source: org_study_id