NCT04813510Unknown不适用
Effect of Electroacupuncture on SAP With MODS: a Prospective, Double-blind, Randomized Controlled Trial
Jianbo Yu0 个研究点目标入组 110 人开始时间: 2021年12月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 主要终点
- All-cause 28-day mortality
研究概览
简要总结
- Title: Effect of Electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome patients: A Randomized Clinical Trial
- Research center: single center
- Design of the research: A randomized, double-blind and parallel controlled study
- Object of the research: The patients over 18 years that met the criteria of SAP and with more than 2 organs failure.
- Sample size of the research: A total of 220patients,110 cases in each group
- Interventions: The acupuncture points for electroacupuncture are Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) points . Participants in the treatment group underwent 30 minutes acupuncture (0.30mm×70mm) at above points once 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 nonacupoints (located 1 inch beside acupoints). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no "Deqi" without actual current output.
- Aim of the research: To investigate the effect of electroacupuncture on Severe Acute Pancreatitis with Multiple Organ Disfunction Syndrome.
- Outcome #Primary outcomes: All-cause 28-day mortality. Secondary outcomes: Duration of organ failure; The incidence of pancreatic necrotic tissue infection; Time for enteral nutrition to reach the standard (30kcal/kg); Mechanical ventilation time; Length of hospital stay
- The estimated duration of the study#2 years.
详细描述
This study is a randomized, double-blinded, placebo controlled and long-term follow-up design. In this study, Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) were selected for electroacupuncture treatment, accompanied with evaluating the effects on 28-day mortality in SAP patients with MODS, as well as the duration of organ failure, the incidence of pancreatic necrotic tissue infection and length of hospital stay . To clarify the effect of electroacupuncture on SAP patients with MODS 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 diagnosis of severe acute pancreatitis (Atlanta diagnostic criteria), within 1 week of onset
- •Combine 2 or more organ failures at the same time, and the duration is greater than 48h
- •Age ≥18 years old;
- •Obtain informed consent.
排除标准
- •Pregnancy pancreatitis;
- •Patients who have undergone percutaneous puncture or surgical drainage before admission, and have undergone surgical decompression due to early abdominal hypertension;
- •Patients with a history of chronic organ dysfunction (such as uremia, COPD, liver cirrhosis, heart failure, etc.).
- •Those who have a medical history of acupuncture and moxibustion or are not sensitive to acupuncture and moxibustion.
- •Those who refuse to participate in the research
结局指标
主要结局
All-cause 28-day mortality
时间窗: 1-2year
All reasons (such as infection, hemorrhage) caused the mortality during the first 28 days after treatments
次要结局
- Length of stay in hospital(24 months)
- The incidence of pancreatic necrotic tissue infection(up to one year)
- Duration of organ failure(an average of 1-2 year)
- Duration of mechanical ventilation in patients with endotracheal intubation in ICU(an average of 1 year)
研究者
Jianbo Yu
Department of Anesthesiology, Director, Chief physician, Professor, Doctoral tutor
Tianjin Nankai Hospital
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