A Retrospective Study on Diagnosis and Treatment of End Stage Liver Disease Complicated With Infection (SESLDIR Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Complete response rate to empirical antibiotic treatment
研究概览
简要总结
The term of End Stage of Liver Disease (ESLD) was raised in 80's of 20 Century, but without a restrict definition. Infections are the cause and effect in occurrence and development of ESLD, which not only induce or exacerbate ESLD, but also are the most combined complication. Multi-resistant bacteria, multi-organ injury, selection of anti-microbes, supporting treatment, disorder of intestine microbiota, et al are dilemma in clinical practice. Appropriate and formal diagnosis and treatment of ESLD combined infection are imperious nowadays.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Decompensation of liver cirrhosis:
- •ALB <35 g / L; A / G <1.0
- •TBIL> 35μmol / L;
- •ALT> 1 × ULN and / or AST> 1 × ULN
- •Ascites or hepatic encephalopathy or esophageal variceal bleeding
- •Acute-on-chronic liver failure:
- •Chronic liver disease based on: chronic hepatitis or decompensated cirrhosis
- •onset time: <4 weeks
- •Hepatic encephalopathy: with or without
- •Coagulation: PTA ≤ 40% or INR ≥ 1.5
- •Jaundice: TBIL ≥ 171μmol / L or daily increase ≥ 17.1μmol / L
- •Chronic liver failure:
- •The basis of chronic liver disease: decompensated cirrhosis
- •onset time: -
- •Hepatic encephalopathy: with or without
- •Coagulation: PTA ≤ 40% or INR ≥ 1.5 Jaundice: significantly higher
排除标准
- 未提供
研究组 & 干预措施
Infection Group
Patients with end stage liver disease with infection
干预措施: Antibiotics (Drug)
结局指标
主要结局
Complete response rate to empirical antibiotic treatment
时间窗: 6 months
The percentage of patients who achieved complete recovery from combined infection after empirical antibiotic treatment
次要结局
- Non-liver transplant survival(6 months)
- Hospitalization time(6 months)
研究者
Qin Ning
Director of Department of Infectious Disease
Tongji Hospital