Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04646629
• Other study ID #: NKYY_YXKT_IRB_2020_071_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2020
• Source: Tianjin Nankai Hospital
• Contact: Yingya Cao, MD
• Phone: 15055324662
• Email: caoyingya1990[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Dysfunction
• Sepsis
• Toxemia

Intervention

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 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

Locations

Country	Name	City	State
China	Electroacupuncture Apparatus	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jianbo Yu

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect on intestinal motility	Record the serum levels of motilin of the two groups	an average of one year
Primary	The effect on intestinal motility	Record the serum levels of gastrin of the two groups	an average of 1 year
Primary	The effect on intestinal barrier	Record serum levels of DAO of the two groups	up to 1 year
Primary	The effect on intestinal barrier	Record serum levels of I-FABP of the two groups	up to 12 months
Secondary	Duration of mechanical ventilation in patients with endotracheal intubation in ICU	Duration of mechanical ventilation and endotracheal intubation in ICU	one year
Secondary	Length of stay in hospital	ICU stay time and hospitalization time	up to one year
Secondary	All-cause 28-day mortality	All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days	12 months