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

NCT ID: NCT06142968

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute-On-Chronic Liver Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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laboratory tests

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Nardin Nadi Roshdy Saweres

Principle invistegator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Nardin Nadi Roshdy Saweres, Master

Role: CONTACT

01281129495

DR.Effat Abdl hady El tony, doctor

Role: CONTACT

References

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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.

Reference Type RESULT
PMID: 27277335 (View on PubMed)

Related Links

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Other Identifiers

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ACLF

Identifier Type: -

Identifier Source: org_study_id