Acute on Chronic Liver Failure in Cirrhotic Patients at Assiut University Hospitals

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

Incidence and Outcomes of Acute on Chronic Liver Failure (ACLF) in Cirrhotic Patients at Assiut University Hospitals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06142968
• Other study ID #: ACLF
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: October 2026

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Nardin Nadi Roshdy Saweres, Master
• Phone: 01281129495
• Email: lollaz.fabio[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.

Description:

Liver cirrhosis is the result of progressive fibrosis in patients with chronic liver disease of any etiology, and is associated with a poor prognosis, once hepatic decompensation starts.

Cirrhosis has two main phases: the compensated phase, where patients maintain preserved liver synthetic function and have no significant extrahepatic organ impairment; this is to be compared with a decompensated phase, where increasing ascites and loss of liver synthetic function, together with presentation with other organ impairment, are common clinical presentations. Renal failure, hepatic encephalopathy (HE), recurrent infections and upper gastrointestinal bleeding from worsening portal hypertension are considered end- stage complications of decompensated cirrhosis. The term acute- on- chronic liver failure (ACLF) is used to describe the clinical syndrome where acute hepatic decompensation leads to organ failures in the setting of liver cirrhosis.

Although there is not a universal agreement about the definition of acute on chronic liver failure (ACLF), there is a wide agreement that ACLF is a distinct syndrome that is different from chronic progressive hepatic decompensation. In most cases of ACLF, patients present initially with clinical manifestations of a decompensating event, usually renal impairment, worsening of abdominal ascites, jaundice or Hepatic encephalopathy (HE) and often precipitated by bacterial infection.

In the CANONIC study, ACLF was defined as 'an acute deterioration of pre- existing chronic liver disease, sometimes related to a clear precipitating event, and associated with increased mortality at 28 days.

The North American consortium for studying liver disease (NACSELD) proposed another definition of ACLF that defines it as 'a condition in patients with underlying chronic liver disease with or without cirrhosis that is associated with mortality within 3 months in the absence of treatment of the underlying liver disease, liver support, or liver transplantation'.

Currently, the term ACLF is still a relatively new entity that has not been very well studied or investigated in our medical research environment. There are no major studies that aimed at looking at the incidence of ACLF in our medical settings.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: October 2026
• Est. primary completion date: January 2024
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

• all cirrhotic patients who will be admitted to our intensive care unit in our hospital meeting the criteria of defention of ACLF according to the CANONIC trial and The European Association for the Study of the Liver graded with chronic liver failure organ failure scor ( CLIF-OF )

Exclusion Criteria:

• 1- children less than 16 years 2- adult more than 70 years 3- patients with Hepatocellular carcinoma 4- patients known to be Chronic kidney disease

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• laboratory tests
Laboratory tests inform of Complete blood count , liver function tests , kidney function tests abdominal ultrasound

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (1)

Arroyo V, Moreau R, Kamath PS, Jalan R, Gines P, Nevens F, Fernandez J, To U, Garcia-Tsao G, Schnabl B. Acute-on-chronic liver failure in cirrhosis. Nat Rev Dis Primers. 2016 Jun 9;2:16041. doi: 10.1038/nrdp.2016.41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHILD Pugh score	Child-Pugh A: 5 to 6 points. Child-Pugh B: 7 to 9 points. Child-Pugh C: 10 to 15 points.	baseline
Secondary	ACLF score ( acute on chronic liver failure score )	higher scores represent bad outcomes , higher mortality	baseline

External Links

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