CClinicalTrials.gg
Status unknownNCT04186572ARIHACUpdated Dec 10, 2019

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

An observational study in Acute-On-Chronic Liver Failure, sponsored by Hospital El Cruce. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by Hospital El Cruce · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute-On-Chronic Liver Failure

Keywords

  • Acute-On-Chronic Liver Failure
  • Liver Failure
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In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's planned enrollment of 30 is below the median of 129 across 146 observational studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

Hospital El Cruce is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with liver cirrhosis with ACLF over 18 years.

Inclusion criteria

  • Acute on Chronic Liver Failure

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes
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What researchers measure

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.

    Time frame: one week

Secondary outcomes

  1. 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.

    Time frame: 90 days

  2. ACLF epidemiological evaluation.

    Incidence, prevalence of ACLF will be determined. Triggers (hepatic and / or extra hepatic causes).

    Time frame: 90 days

  3. 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

    Time frame: 1 day

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 23474284 ↗
  • 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. PubMed 22750750 ↗
  • 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. PubMed 25877702 ↗
  • 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. PubMed 24677131 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04186572
Lead sponsor
Hospital El Cruce
Responsible party
Nestor Pistillo (Head of Intensive Care Unit at Hospital El Cruce, Hospital El Cruce) — Principal investigator
First posted
Dec 5, 2019
Start date
Dec 2019 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2021 (estimated)
Last update
Dec 10, 2019

Study contacts

Nestor Pistillo, MD
Contact
npistillo@yahoo.com.ar
54-011 4210-9000 ext. 5636
José I Retta, MD
Contact
ignacioretta@gmail.com
54-011 4210-9000 ext. 5636

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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