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

• Conditions: Acute-On-Chronic Liver Failure

• Registration Number: NCT04186572
• Lead Sponsor: Hospital El Cruce

Brief Summary

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.

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 Timeline

• Status Verified: 2019-12
• Study Start: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-10
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Acute on Chronic Liver Failure

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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.

Secondary Outcome Measures

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