Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction: a Prospective, Double-blind, Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The effect on intestinal motility
Study Overview
Brief Summary
- Title: Effect of electroacupuncture on sepsis-induced intestinal dysfunction
- Research center: single center
- The Design of the study: Randomized, double-blind, controlled study
- 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
- Sample size: Enroll 60 patients (30patients in each group)
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meet the diagnostic criteria of sepsis 3.0
- •AGI grade II or above,
- •At least 18 years old
- •Volunteer to participate in this study and sign the informed consent form
Exclusion Criteria
- •Patients with bowel dysfunction caused by other diseases or surgical operations
- •Those who have chronic gastrointestinal diseases such as Crohn's disease and ulcerative colitis
- •Those who have recently used gastrointestinal motility drugs and within 5 times the half-life
- •Those who are participating in other drug clinical trials
- •Refuse to participate in this study
Outcomes
Primary Outcomes
The effect on intestinal motility
Time Frame: an average of 1 year
Record the serum levels of gastrin of the two groups
The effect on intestinal barrier
Time Frame: up to 12 months
Record serum levels of I-FABP of the two groups
Secondary Outcomes
- Duration of mechanical ventilation in patients with endotracheal intubation in ICU(one year)
- Length of stay in hospital(up to one year)
- All-cause 28-day mortality(12 months)
Investigators
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital