Copenhagen Liver Cohort Study: Disease Characteristics, Outcomes and Rehabilitation in Liver Cirrhosis - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Improve risk of decompensation in cirrhosis
研究概览
简要总结
A population based incidence cohort will enroll patients newly diagnosed with cirrhosis to investigate disease characteristics and outcomes, explore mechanisms predicting early death and hospital admission, and assess new monitoring tools in treatment and prevention of cirrhosis.
详细描述
INTRODUCTION In Denmark the incidence of liver cirrhosis is increasing. From 1996 to 2005 the number of hospital admissions due to liver cirrhosis rose with 2,500 extra admissions per year. Patients who are readmitted to the hospital have a higher 90 days mortality than those who avoid readmission.
Liver cirrhosis in Denmark is caused by a wide use of alcohol and a population increasing in age and BMI.
The course of cirrhosis depends on etiology, age and nutritional status, as well as social factors such as personal network, employment and economy. Interventional studies on many of these mechanisms are still unexplored.
Cirrhosis is related to decreased quality of life and affects patients and relatives both emotional and socioeconomically.
The Gastro Unit, Amager Hvidovre Hospital has a catchment area of 550,000 citizens in South and West of Copenhagen. The Gastro Unit diagnoses app. 140 people with liver cirrhosis yearly.
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
- •Clinical suspicion of cirrhosis supported by biochemistry and ultrasound or other imaging techniques.
- •Cirrhosis of any etiology
- •Informed written consent
排除标准
- •People where the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging.
- •Withdrawal of informed consent or no informed consent.
- •Persons eligible for inclusion where the investigational program is delayed or not initiated within six months after the diagnosis of suspected cirrhosis.
结局指标
主要结局
Improve risk of decompensation in cirrhosis
时间窗: 5 years
time to development of decompensation
Survival
时间窗: 5 years
Time from diagnosis to death or liver transplantation
次要结局
- Risk prediction by Short Physical Performance Battery(5 years)
- Social impact of cirrhosis(5 years)
- Characterization of patients(5 years)
- Life space Assessment(5 years)
研究者
Nina Kimer
MD, PhD
Copenhagen University Hospital, Hvidovre