Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Occurrence of bacterial infection
研究概览
简要总结
Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
- •Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin >=85mmol/L and international normalized ratio (INR)>=1.5 with a definite hepatic insult.
排除标准
- •(1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;
结局指标
主要结局
Occurrence of bacterial infection
时间窗: Within 3 months from admission
Site,source, pathogen and severity
次要结局
- 28-day Mortality(Within 28 days after enrollment)
- 90-day Mortality(Within 90 days after enrollment)
研究者
Shi Yu
Principal Investigator
The Zhejiang Study Group for Organ Failure in Cirrhosis