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NCT Number: NCT06142968

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

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.

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Key information

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laboratory tests

Diagnostic Test

Laboratory tests inform of Complete blood count , liver function tests , kidney function tests abdominal ultrasound

Primary outcomes

  1. CHILD Pugh score

    Time frame: baseline

    Child-Pugh A: 5 to 6 points. Child-Pugh B: 7 to 9 points. Child-Pugh C: 10 to 15 points.

Secondary outcomes

  1. ACLF score ( acute on chronic liver failure score )

    Time frame: baseline

    higher scores represent bad outcomes , higher mortality

Study contacts

Contact information is provided by the study sponsor or research team.

DR.Effat Abdl hady El tony, doctor

CONTACT

Nardin Nadi Roshdy Saweres, Master

CONTACT

[email protected]

01281129495

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 22, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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