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

Acute-On-Chronic Liver Failure Clinical Trial

— ARIHAC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04186572
• Other study ID #: HCruce
• Status: Not yet recruiting
• Start date: December 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Hospital El Cruce
• Contact: Nestor Pistillo, MD
• Phone: 54-011 4210-9000
• Email: npistillo[@]yahoo.com.ar
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Acute on Chronic Liver Failure

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital El Cruce

References & Publications (4)

Bajaj JS, O'Leary JG, Reddy KR, Wong F, Biggins SW, Patton H, Fallon MB, Garcia-Tsao G, Maliakkal B, Malik R, Subramanian RM, Thacker LR, Kamath PS; North American Consortium For The Study Of End-Stage Liver Disease (NACSELD). Survival in infection-related acute-on-chronic liver failure is defined by extrahepatic organ failures. Hepatology. 2014 Jul;60(1):250-6. doi: 10.1002/hep.27077. Epub 2014 May 29. — View Citation

Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solís-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepción M, Córdoba J, McCormick A, Stauber R, Vogel W, de Gottardi A, Welzel TM, Domenicali M, Risso A, Wendon J, Deulofeu C, Angeli P, Durand F, Pavesi M, Gerbes A, Jalan R, Moreau R, Ginés P, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL-CLIF Consortium. Clinical Course of acute-on-chronic liver failure syndrome and effects on prognosis. Hepatology. 2015 Jul;62(1):243-52. doi: 10.1002/hep.27849. Epub 2015 May 29. — View Citation

Jalan R, Gines P, Olson JC, Mookerjee RP, Moreau R, Garcia-Tsao G, Arroyo V, Kamath PS. Acute-on chronic liver failure. J Hepatol. 2012 Dec;57(6):1336-48. doi: 10.1016/j.jhep.2012.06.026. Epub 2012 Jun 28. Review. — View Citation

Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V; CANONIC Study Investigators of the EASL–CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology. 2013 Jun;144(7):1426-37, 1437.e1-9. doi: 10.1053/j.gastro.2013.02.042. Epub 2013 Mar 6. — View Citation

Outcome

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