Acute-On-Chronic Liver FailureARIHACNCT04186572
Usefulness of the Variation of the CLIF-C ACLF Score in Patients With Acute on Chronic Liver Failure
An observational study of Acute-On-Chronic Liver Failure, run by Hospital El Cruce.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2019to Dec 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with liver cirrhosis with ACLF over 18 years.
Who may be able to join
- Acute on Chronic Liver Failure
Who cannot join
- Acute liver failure, terminal disease, pregnancy, previous liver transplant
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- Acute-On-Chronic Liver Failure, Liver Failure
- Medical subject headings
- Acute-On-Chronic Liver Failure, Liver Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week
Secondary outcomes (3)
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.
Measured: 90 days
ACLF epidemiological evaluation.
Incidence, prevalence of ACLF will be determined. Triggers (hepatic and / or extra hepatic causes).
Measured: 90 days
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study startDec 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hospital El Cruce
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nestor Pistillo, Hospital El Cruce
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186572
- Sponsor's protocol ID
- HCruce
- Acronym
- ARIHAC
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23474284Jalan 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 22750750Gustot 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 25877702Bajaj 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of the Variation of the CLIF-C ACLF Score in Patients With Acute on Chronic Liver Failure
- ClinicalTrials.gov ID
- NCT04186572
- Acronym / sponsor ID
- ARIHAC / HCruce
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- Acute-On-Chronic Liver Failure, Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital El CruceUniversity, hospital or other
- Study start
- Dec 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 5 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with liver cirrhosis with ACLF over 18 years.
Key inclusion criteria (1 listed)
- Acute on Chronic Liver Failure
Key exclusion criteria (1 listed)
- Acute liver failure, terminal disease, pregnancy, previous liver transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Correlate the variation of the score (CLIF-C ACLF) and mortality at 28, 60 and 90 days.
Time frame: 90 days
ACLF epidemiological evaluation.
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Background: PubMed 23474284Moreau 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.
- Background: PubMed 22750750Jalan 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.
- Background: PubMed 25877702Gustot 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.
- Background: PubMed 24677131Bajaj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Hospital El Cruce.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nestor Pistillo, MD (54-011 4210-9000 ext. 5636, npistillo@yahoo.com.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04186572, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2019.