Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction

Not Applicable

• Conditions: Sepsis; Intestinal Dysfunction
• Interventions: Device: electroacupuncture treatment; Device: sham electroacupuncture treatment

• Registration Number: NCT04646629
• Lead Sponsor: Jianbo Yu

Brief 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.

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-22
• Study Start: 2020-11-23
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-11-30
• Last Update Posted: 2020-11-30
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroacupuncture 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) isconnected and maintained the end of treatment
sham electroacupuncture 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.

Primary Outcome Measures

Name	Time	Method
The effect on intestinal motility	an average of 1 year	Record the serum levels of gastrin of the two groups
The effect on intestinal barrier	up to 12 months	Record serum levels of I-FABP of the two groups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Electroacupuncture Apparatus; 🇨🇳 Tianjin, China