ACLARA STUDY

PI: Flair Carrilho
(Hospital das Clínicas, Sao Paulo, Brasil).

Promoter: EF Clif

The ACLF-ACLARA Study is a prospective follow-up observational investigation in 1,300 patients with cirrhosis hospitalized for AD with and without ACLF at 56 hospitals, designed to assess the characteristics of the ACLF syndrome in Latin America.

Latin America is one of the regions where epidemiological studies of diseases promoted by systemic inflammation, such as ACLF, are of special interest. First, the prevalence and severity of ACLF has been reported to be very high in young individuals with cirrhosis and active alcoholism, a common subset of patients in Latin American countries. Secondly, the role of ethnicity on the severity and mortality of diseases, associated with systemic inflammation (i.e., sepsis) is a well-recognized feature in multiracial countries such the United States. Mortality is significantly higher in African Americans, followed by Amerindians, Caucasians and Oriental.

Finally, there are very few data on ACLF in Latin America, and three performed studies show that the mortality rate of patients with is double than in Europe (60% vs 32%). Therefore, it is very likely that ACLF could represent a major health care problem in the whole Latin American continent, and particularly in those countries with high percentage of African Americans (Brazil, Panama and Colombia), and Amerindians (Mexico, Colombia and Peru), as compared with countries with high proportion of Caucasians (Argentina and Chile).

The ACLARA Study is a joined project between the EF Clif, the European CLIF Consortium, and the Latin American CLIF Consortium. It will consist of a prospective follow-up observational investigation in 1,300 consecutive patients with cirrhosis hospitalized for AD with and without ACLF.

Clinical and standard laboratory data and samples for measuring circulating levels of inflammatory inducers and mediators, biomarkers of systemic circulatory dysfunction and oxidative stress, innate immune cell function and cell death, and genotyping (only assessed at enrolment), transcriptomics and metabolomics will be obtained at admission, eight days after admission and at hospital discharge. The one-year clinical course (survival, liver transplantation and causes of death) will also be recorded.

During the year 2019 there were 47 active centres in Argentina, Brazil, Colombia, Chile, which included 1,197 patients. Recruitment is expected to go on until May 2020.

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