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

NCT04186572 | Unknown DMC

• 1 other identifier: HCruce
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute-On-Chronic Liver Failure

Keywords

Acute-On-Chronic Liver Failure; Liver Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlate the variation of the score (CLIF-C ACLF) and mortality at 28, 60 and 90 days.

  90 days

• ACLF epidemiological evaluation.

  90 days

• Correlate the level of NGAL with the development of ACLF and its severity evaluated by the CLIF-C ACLF score.

  1 day

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver cirrhosis with ACLF over 18 years.

You may qualify if:

• Acute on Chronic Liver Failure

You may not qualify if:

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

Sponsors & Collaborators

• Hospital El Cruce: lead

Related Publications (4)

• 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.

  PMID: 23474284 BACKGROUND

• 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.

  PMID: 22750750 BACKGROUND

• Gustot T, Fernandez J, Garcia E, Morando F, Caraceni P, Alessandria C, Laleman W, Trebicka J, Elkrief L, Hopf C, Solis-Munoz P, Saliba F, Zeuzem S, Albillos A, Benten D, Montero-Alvarez JL, Chivas MT, Concepcion M, Cordoba 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, Gines 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.

  PMID: 25877702 BACKGROUND

• 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.

  PMID: 24677131 BACKGROUND

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Nestor Pistillo, MD

CONTACT

54-011 4210-9000; npistillo@yahoo.com.ar

José I Retta, MD

CONTACT

54-011 4210-9000; ignacioretta@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Intensive Care Unit at Hospital El Cruce

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: December 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share