The Feasibility of Liver Biomarkers as Prognostic Markers in Decompensated Alcoholic Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Liver Related Death
研究概览
简要总结
Fibroscan is a non invasive imaging investigation which measures liver stiffness, known to correlate well with liver scarring and cirrhosis on liver biopsy. Indocyanine green is an inert dye which is purely extracted from the blood by liver cells, and is hence an excellent marker of both liver cell function and overall liver blood flow. There is little data for either of these biomarkers regarding outcomes in alcoholic liver disease. We aim to establish the accuracy of these liver biomarkers in predicting important liver related outcomes (death, transplantation and hospital readmission with cirrhosis related consequences) in patients with severe (decompensated) alcoholic liver disease. Moreover, we will assess whether the serial measurement of biomarkers has any impact on alcohol abstinence, motivation or quality of life. Over an 18 month period, 125 consecutive hospital inpatients with decompensated alcoholic liver disease will undergo baseline biomarker measurement, routine blood and urine tests and qualitative questionnaires. These will be measured during their initial hospital admission (0 months) with subsequent repeat measurement during follow up visits at 1, 2, 4 and 6 months. Each study visit time will be in the region of 30-40 minutes to complete these investigations. The end of the study for individual patients will be patient death, liver transplantation or 6 month from study enrolment; whichever occurs first.
详细描述
This is a single centre longitudinal cohort feasibility pilot study of patients with decompensated alcoholic liver disease. We aim to recruit 125 consecutive patients with decompensated alcoholic liver disease over an 18 month period. This number is based upon approximately 10 admissions per month to acute liver services with decompensated alcoholic liver disease and includes a presumed 20% dropout rate during follow up, giving a total cohort of 100 patients. Patients will undergo a maximum of 6 months follow up following study recruitment.
The purposes of this study are:
- To assess the performance of diagnostic liver biomarkers (Indocyanine Green, Fibroscan and blood and urinary biomarkers) in predicting mortality in decompensated alcoholic liver disease.
- To compare the diagnostic and prognostic end points of these biomarkers with existing cirrhosis prognostic scoring systems (Child Pugh, MELD and UKELD).
- To assess the performance of diagnostic biomarkers as a therapeutic aid to quality of life and alcohol abstinence.
Potentially eligible patients i.e. adults with decompensated liver disease with alcohol as a major co-factor, and acutely admitted secondary to sequelae of hepatic decompensation, will be approached by an existing member of their clinical care team (The CI & Co-Investigators form part of this team). Any patient who decides to take part in the study will have a baseline inpatient study visit either on their inpatient ward or to the NDDC Biomedical Research Unit (BRU). Subsequent follow up visits will be to the BRU.
Inclusion Criteria:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18-75 years of age
- •Diagnosis of cirrhosis based upon:
- •a) Histological confirmation
- •b) Combination of clinical and radiological criteria
- •c) Validated non invasive biomarker
- •Alcohol as the primary aetiology for liver cirrhosis
- •Hospital admission related to decompensated liver disease (e.g. ascites, varices, sepsis, alcoholic hepatitis)
- •Active alcohol drinking prior to index hospital admission
排除标准
- •Grade 3 or 4 hepatic encephalopathy
- •Hepatocellular carcinoma
- •Active non hepatic malignancy
- •Known complete portal vein thrombosis
- •Alcohol abstinence at time of index hospital admission
- •Pregnancy
- •Active cardiac devices (e.g. cardiac pacemaker, implantable cardioverter defibrillator)
结局指标
主要结局
Liver Related Death
时间窗: 6 months
The proportion of deaths up to 6 months from the baseline visit directly attributable to consequences of cirrhosis
次要结局
- Hospital Readmission(6 months)
- Alcohol abstinence(6 months)
- Non-Liver related death(6 months)