Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction: a Prospective, Double-blind, Randomized Controlled Trial

1. Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction
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.

Study Overview

• Status: Unknown
• Conditions: Sepsis; Intestinal Dysfunction
• Intervention / Treatment: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

Detailed Description

This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, ST36 (Zusanli) and ST37 (Shangjuxu) were selected for electroacupuncture treatment, accompanied with evaluating the effects on intestinal function in septic patients. Meanwhile, the blood biochemical indexes such as heme oxygenase-1(HO-1), PTEN induced putative kinase 1(PINK1), polo-like kinase 1(PLK1) and interleukin-6 are detected. To clarify the effect of electroacupuncture on sepsis-induced intestinal dysfunction is of great significance to the clinical applications and popularization of traditional acupuncture treatment across the world.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingya Cao, MD; Phone Number: 15055324662; Email: caoyingya1990@126.com

Study Locations

• China
  • Tianjin, China
    • Electroacupuncture Apparatus
    • Contact: Yingya Cao, MD; Phone Number: 15055324662; Email: caoyingya1990@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet the diagnostic criteria of sepsis 3.0
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:

1. Patients with bowel dysfunction caused by other diseases or surgical operations
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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 Comparator: 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.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect on intestinal motility	Record the serum levels of motilin of the two groups	an average of one year
The effect on intestinal motility	Record the serum levels of gastrin of the two groups	an average of 1 year
The effect on intestinal barrier	Record serum levels of DAO of the two groups	up to 1 year
The effect on intestinal barrier	Record serum levels of I-FABP of the two groups	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of mechanical ventilation in patients with endotracheal intubation in ICU	Duration of mechanical ventilation and endotracheal intubation in ICU	one year
Length of stay in hospital	ICU stay time and hospitalization time	up to one year
All-cause 28-day mortality	All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days	12 months

Collaborators and Investigators

• Sponsor: Jianbo Yu
• Investigators: Study Chair: Jianbo Yu, PhD, Tianjin Nankai Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 23, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: November 22, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): November 30, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: sepsis; electroacupuncture; intestinal dysfunction
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia
• Other Study ID Numbers: NKYY_YXKT_IRB_2020_071_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No