The Study of Dachengqi Decoction Combined With Probiotic L92 to Improve the Prognosis of Patients With Severe Abdominal Hypertension
试验速览
- 阶段
- 2 期
- 入组人数
- 752
- 主要终点
- Incidence of sepsis within 7 days
研究概览
简要总结
Patients with severe infections, wounds (burns), and severe pancreatitis often have abdominal hypertension (IAH), which is an important objective manifestation of acute gastrointestinal failure in severe patients. Timely diagnosis and effective intervention can improve the treatment rate of patients. In the early stage, we conducted clinical exploration and observational research on the treatment of IAH with Dachengqi Decoction and Lactobacillus in the treatment of critically ill patients including the above diseases, and achieved significant clinical effects. On this basis, it is planned to verify the protective effect of Lactobacillus acidophilus L92, Dachengqi Decoction and the combination of the two on the gastrointestinal mucosal barrier function of patients with IAH and the regulation of the intestinal flora, and analyze the intestinal mucosal barrier The relationship between intestinal flora and the prognosis of IAH patients.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion and exclusion criteria and critically ill patients (acute severe pancreatitis, cervical spinal cord injury) who are 60 years old or older than 18 years old, expected to be mechanically ventilated in the ICU, and hospitalized for more than 48 hours, replaced intra-abdominal pressure monitoring with bladder pressure measurement, and repeated on admission The results of the three measurements are ≥12 mmHg.
排除标准
- •Patients who have not signed the informed consent; cannot tolerate intra-abdominal pressure monitoring; pregnant women; patients after bladder surgery; systemic diseases and recent use of related drugs; previous infections, such as history of tuberculosis or PPD positive; previous high History of blood pressure, poor blood pressure control (SBP/DBP>=140mmHg); patients with severe mental illness; long-term use of traditional Chinese medicine, probiotics, gastric mucosal protectors, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc., such as admission The drug was not discontinued within the previous month.
研究组 & 干预措施
Conventional treatment plus Dachengqi decoction group
Conventional treatment combined with Dachengqi Decoction
干预措施: Conventional treatment (Other)
Conventional treatment group
Control the primary disease, prevent infection, reduce gastrointestinal decompression, and actively maintain organ function.
干预措施: Conventional treatment (Other)
Conventional treatment plus L92 group
Conventional treatment combined with L92
干预措施: probiotic L9 (Drug)
Conventional treatment plus L92 group
Conventional treatment combined with L92
干预措施: Conventional treatment (Other)
Conventional treatment plus Dachengqi decoction group
Conventional treatment combined with Dachengqi Decoction
干预措施: Dachengqi decoction (Drug)
Conventional treatment plus Dachengqi decoction plus L92 group
Conventional treatment combined with L92 and Dachengqi Decoction
干预措施: Dachengqi decoction (Drug)
Conventional treatment plus Dachengqi decoction plus L92 group
Conventional treatment combined with L92 and Dachengqi Decoction
干预措施: probiotic L9 (Drug)
Conventional treatment plus Dachengqi decoction plus L92 group
Conventional treatment combined with L92 and Dachengqi Decoction
干预措施: Conventional treatment (Other)
结局指标
主要结局
Incidence of sepsis within 7 days
时间窗: six months
次要结局
未报告次要终点
研究者
Chengjing Gao
Chief Physician
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine