Effect of Electroacupuncture on Sepsis-induced Intestinal Dysfunction: a Prospective, Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The effect on intestinal motility
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The effect on intestinal motility
时间窗: an average of 1 year
Record the serum levels of gastrin of the two groups
The effect on intestinal barrier
时间窗: up to 12 months
Record serum levels of I-FABP of the two groups
次要结局
- 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)
研究者
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital