Usefulness of the Variation of the CLIF-C ACLF Score in Patients With Acute on Chronic Liver Failure (ARIHAC)

December 6, 2019 updated by: Nestor Pistillo, Hospital El Cruce

Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective or futile.

Study Overview

Status

Unknown

Conditions

Acute-On-Chronic Liver Failure

Detailed Description

Acute on Chronic Liver Failure (ACLF) is a syndrome characterized by the presence of an acute decompensation of cirrhosis, associated with failure of at least one other organ or extra hepatic system. It is characterized by high mortality in the short term and its prevalence varies between countries and regions.

It is an extraordinarily dynamic entity in which more than 50% of patients with less severe forms improve, while in those with 3 or more organ failures, the transplant rate is low and mortality is 90%. It is important to highlight that those patients with ACLF who manage to be transplanted have the same survival as cirrhotic patients without ACLF. There is no specific treatment, only life support and early determination of the precipitating factor and its eventual resolution.

Having tools that define the short-term prognosis of these patients, especially the variation of the score (CLIF-C ACLF) during the first week, would have an important clinical relevance, because it can help define the patients who benefit from the supportive treatment and in whom the therapeutic effort is futile.

The biomarker Neutrophil Gelatinase-Associated Lipocalin (NGAL) is increased in plasma and urine in patients with ACLF and could help improve the prognostic ability of the CLIF-C ACLF score.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with liver cirrhosis with ACLF over 18 years.

Description

Inclusion Criteria:

Acute on Chronic Liver Failure

Exclusion Criteria:

Acute liver failure, terminal disease, pregnancy, previous liver transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the degree of severity of the ACLF with the CLIF-C ACLF score at the time of diagnosis and its variation on day 3 and 7 Time Frame: one week	The severity of the ACLF will be assessed by means of a score (CLIF_C ACLF) at the time of admission, day three and seven. Good evolution of the score will be considered when it decreases and bad evolution when it remains the same or increases.	one week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlate the variation of the score (CLIF-C ACLF) and mortality at 28, 60 and 90 days. Time Frame: 90 days	The variation of the score (good or bad evolution) will be correlated with mortality at 28, 60 and 90 days.	90 days
ACLF epidemiological evaluation. Time Frame: 90 days	Incidence, prevalence of ACLF will be determined. Triggers (hepatic and / or extra hepatic causes).	90 days
Correlate the level of NGAL with the development of ACLF and its severity evaluated by the CLIF-C ACLF score. Time Frame: 1 day	The level of NGAL in plasma and urine will be determined routinely at the time of diagnosis	1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital El Cruce

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 3, 2019

First Submitted That Met QC Criteria