Infections and Other Complications of Cirrhosis: A Prospective Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 385
- 主要终点
- Patterns and adequacy of albumin use in infected and non-infected patients
研究概览
简要总结
Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas:
- Community-acquired infections
- Nosocomial infections
- Development of second infections
- Factors predicting ICU care, organ failure, death, and disability
- Patterns and adequacy of albumin use in infected and non-infected patients
- Per and post-liver transplant outcomes
- Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
- Regional variations in outcomes and therapeutic strategies
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
- •Male and Female over 18 years of age
- •Cirrhosis as diagnosed by either liver histology or a combination of clinical biochemical (low platelets, elevated bilirubin, and/or INR, low albumin) radiologic (nodular liver on ultrasound) and endoscopic (esophageal varices) criteria
- •Subject must be able to understand and provide informed consent
- •Evaluated in the ER or admitted to the hospital for non-elective reasons
排除标准
- •admitted for elective purpose
结局指标
主要结局
Patterns and adequacy of albumin use in infected and non-infected patients
时间窗: From admission to 1 year post-discharge from the hospital
IV albumin administration
Regional variations in outcomes and therapeutic strategies
时间窗: From admission to 1 year post-discharge from the hospital
Comparison of data between sites conducting this study across the United States and Canada
Frequency, Cause and Outcome of Community-acquired infections
时间窗: From admission to 1 year post-discharge from the hospital
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Frequency, Cause, and Outcome of Nosocomial infections
时间窗: From admission to 1 year post-discharge from the hospital
Collecting details of infections including type, organism, antibiotic used, length of stay, ICU stay and outcomes
Development of second infections
时间窗: From admission to 1 year post-discharge from the hospital
Distinctly different from primary infection
Factors predicting ICU care, organ failure, death, and disability
时间窗: From admission to 1 year post-discharge from the hospital
Admission to the ICU and events/outcomes of that subject's admission
Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
时间窗: From admission to 1 year post-discharge from the hospital
Blood test and other obvious clinical evidence of decompensation
Peri and post-liver transplant outcomes based on physiological parameters
时间窗: From admission to 1 year post-discharge from the hospital
Collection of liver transplant donor and recipient information such as blood group, CMV status, post-transplant infections, immunosuppression regimen, and prophylaxis given.
次要结局
未报告次要终点