NCT03456518

Brief Summary

The concept of acute-on-chronic liver failure (ACLF) was introduced by Jalan and Williams in 2002 to describe the acute deterioration in liver function over 2 to 4 weeks in a patient with well-compensated cirrhosis associated with a precipitating event (hepatotoxic: superimposed hepatitis viral infection, drug-induced liver injury, hepatotoxins, or excessive alcohol consumption; extra hepatic: variceal bleeding or sepsis), leading to severe deterioration in clinical status with jaundice and hepatic encephalopathy and/or HRS. Following this concept, several proposals for the diagnostic criteria of ACLF have been suggested.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

12 months

First QC Date

February 23, 2018

Last Update Submit

January 22, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • pattern of acute on chronic liver cell failure

    evaluation of cases with acute on chronic liver cell failure as number of cases diagnosed with ACLF in this period , the precipitating factor of the condition , the fate of the patient (improving or deterioration or death ) in the 28 days following diagnosis .

    march 2018 to march 2019

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CLD patients with HCV related etiology who will admitted to our hospital with picture of acute decompensation and deterioiration of pre-existing liver condition (defined by the development of ascites, encephalopathy, gastrointestinal haemorrhage and/or bacterial infection) associated with either a single organ failure (single renal failure or other single non-renal organ failure if associated with renal and/or brain dysfunction) or multiple organ failures) to meet the criteria of EASL-CLIF definition .

You may qualify if:

  • Adult Patients with HCV related CLD based on clinical, biochemical and imaging evidence., with or without prior decompensation.
  • Patients diagnosed to have ACLIF at any grade (1-3)

You may not qualify if:

  • Acute liver failure without evidence of chronic liver disease.
  • Other etiology of chronic liver disease
  • Patients diagnosed with no ACLIF No ACLF
  • This category includes patients who either:
  • Do not have any organ failure
  • Have a single organ failure that does not involve the kidney with a serum creatinine level of \<1.5 mg per dl and no hepatic encephalopathy
  • Have a single brain failure with a serum creatinine level of \<1.5 mg per dl
  • Patients refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Al-Rajhi Liver Hospital, Assiut University

Asyut, 71515, Egypt

Location

Al-Rajhi liver hospital ,Assiut university

Asyut, Egypt

Location

Related Publications (1)

  • Gines P, Quintero E, Arroyo V, Teres J, Bruguera M, Rimola A, Caballeria J, Rodes J, Rozman C. Compensated cirrhosis: natural history and prognostic factors. Hepatology. 1987 Jan-Feb;7(1):122-8. doi: 10.1002/hep.1840070124.

    PMID: 3804191BACKGROUND

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Study Officials

  • Mohammed Medhat

    Al-Arajhy Liver Hospital, Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 7, 2018

Study Start

November 1, 2018

Primary Completion

October 31, 2019

Study Completion

November 30, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations