Department of Gastroenterology, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Shanghai Institute of Digestive Disease, Key Laboratory of Gastroenterology and Hepatology, Chinese Ministry of Health (Shanghai Jiao Tong University), Shanghai, China.
BMJ Open. 2021 Jan 8;11(1):e037793. doi: 10.1136/bmjopen-2020-037793.
Acute-on-chronic liver failure (ACLF) is a clinical syndrome with high short-term mortality, unclear mechanism and controversial diagnosis criteria. The Chinese Acute-on-Chronic Liver Failure (CATCH-LIFE) study has been conducted in China to fill the gaps. In the first phase (the CATCH-LIFE investigation cohort), 2600 patients were continuously recruited from 14 national nationwide liver centres from 12 different provinces of China in 2015-2016, and a series of important results were obtained. To validate the preliminary results, we designed and conducted this multicentre prospective observational cohort (the CATCH-LIFE validation cohort).
Patients diagnosed with chronic liver disease and hospitalised for acute decompensation (AD) or acute liver injure were enrolled, received standard medical therapy. We collected the participants' demographics, medical history, laboratory data, and blood and urine samples during their hospitalisation.
From September 2018 to March 2019, 1370 patients (73.4% men) aged from 15 to 79 years old were enrolled from 13 nationwide liver centres across China. Of these patients, 952 (69.5%) had chronic hepatitis B, 973 (71.1%) had cirrhosis and 1083 (79.1%) complicated with AD at admission. The numbers and proportions of enrolled patients from each participating centre and the patients' baseline characteristics are presented.
A total of 12 months is required for each participant to complete follow-up. Outcome information (survival, death or receiving liver transplantation) collection and data cleansing will be done before June 2020. The data in the CATCH-LIFE validation cohort will be used for comparison between the new ACLF diagnostic criteria derivated from the CATCH-LIFE investigation cohort with existing ones. Moreover, future proteomic and metabolic omics analyses will provide valuable insights into the mechanics of ACLF, which will promote the development of specific therapy that leads to decrease patients' mortality.
NCT03641872.
急性肝衰竭(ACLF)是一种具有高短期死亡率、机制不明确和诊断标准存在争议的临床综合征。中国急性肝衰竭(CATCH-LIFE)研究在中国进行,旨在填补空白。在第一阶段(CATCH-LIFE 研究调查队列)中,2015 年至 2016 年期间,我们从中国 12 个不同省份的 14 个全国性肝脏中心连续招募了 2600 名患者,并获得了一系列重要结果。为了验证初步结果,我们设计并进行了这项多中心前瞻性观察队列研究(CATCH-LIFE 验证队列)。
纳入诊断为慢性肝病并因急性失代偿(AD)或急性肝损伤住院的患者,接受标准的医学治疗。我们在患者住院期间收集了他们的人口统计学、病史、实验室数据以及血液和尿液样本。
2018 年 9 月至 2019 年 3 月,从中国的 13 个全国性肝脏中心共招募了 1370 名年龄在 15 至 79 岁的患者(73.4%为男性)。这些患者中,952 名(69.5%)患有慢性乙型肝炎,973 名(71.1%)患有肝硬化,1083 名(79.1%)入院时伴有 AD。每个参与中心的入组患者数量和比例以及患者的基线特征。
每位患者需要 12 个月完成随访。在 2020 年 6 月之前,将完成生存、死亡或接受肝移植的结果信息(生存、死亡或接受肝移植)收集和数据清理。CATCH-LIFE 验证队列的数据将用于比较从 CATCH-LIFE 调查队列衍生的新 ACLF 诊断标准与现有标准。此外,未来的蛋白质组学和代谢组学分析将为 ACLF 的机制提供有价值的见解,这将促进特定治疗方法的发展,降低患者死亡率。
NCT03641872。