Natural History of Liver Cirrhosis Diagnosed by Transient Elastography in HIV/HCV-coinfected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 446
- 试验地点
- 8
- 主要终点
- Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up
研究概览
简要总结
Prospective multicenter cohort recruiting consecutive patients from 7 hospitals in Andalusia, southern Spain, according to following criteria: 1) HIV infection, 2) Chronic active HCV infection, 3) Older than 18 years, 4) New diagnosis of liver cirrhosis on the basis of a liver stiffness above 14 kiloPascals, 5) No previous or concomitant decompensation of liver disease. Patients are prospectively followed-up according to a uniform protocol of care. Epidemiological, clinical and laboratory variables are periodically recorded. The primary outcomes are the emergence of a liver decompensation (including hepatocellular carcinoma), liver transplant or death. The predictors of these outcomes are analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Infection
- •HCV chronic active infection (positive serum RNA HCV at inclusion)
- •New diagnosis of cirrhosis on the basis of a liver stiffness equal or greater than 14 kiloPascals.
- •No previous or concomitant decompensation of liver disease
排除标准
- 未提供
结局指标
主要结局
Proportion of patients who developed a first liver decompensation of cirrhosis during follow-up
时间窗: 3 years
Episodes of liver decompensation will include those episodes of ascites, spontaneous bacterial peritonitis, portal hypertensive gastrointestinal bleeding, hepatorrenal syndrome, hepatic encephalopathy, hepatocellular carcinoma, non obstructive jaundice and acute on chronic liver failure. These episodes will be diagnosed according to standard definitions of clinical practice guidelines in the field (i.e. HCC diagnosis will be diagnosed according to AASLD criteria, spontaneous bacterial peritonitis and hepatorenal syndrome will be diagnosed following the EASL criteria, portal hypertensive gastrointestinal bleeding according Baveno VI consensus definition,...)
次要结局
- Liver-related mortality(3 Years)
- All cause mortality(3 Years)
研究者
Nicolás Merchante
MD, PhD
Hospital Universitario de Valme