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Not yet recruitingNCT06142968Updated Nov 22, 2023

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

An observational study in Acute-On-Chronic Liver Failure, sponsored by Assiut University. Not yet recruiting. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-11-22.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2024, 2 years 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
96
Ages
16 Years to 70 Years
Sex
All
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Study 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.

Read the detailed 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.

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Conditions studied

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In context

Liver Failure

445 studies on the registry are indexed under Liver Failure; 69 are open to participants now.

This study's planned enrollment of 96 is below the median of 129 across 146 observational studies indexed under Liver Failure.

Browse Liver Failure studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

all patients with liver cirrhosis

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
96 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testlaboratory tests

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

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What researchers measure

Primary outcomes

  1. CHILD Pugh score

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

    Time frame: baseline

Secondary outcomes

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

    higher scores represent bad outcomes , higher mortality

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 27277335 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06142968
Lead sponsor
Assiut University
Responsible party
Nardin Nadi Roshdy Saweres (Principle invistegator, Assiut University) — Principal investigator
First posted
Nov 22, 2023
Start date
Dec 2023 (estimated)
Primary completion
Jan 2024 (estimated)
Completion
Oct 2026 (estimated)
Last update
Nov 22, 2023

Study contacts

Nardin Nadi Roshdy Saweres, Master
Contact
lollaz.fabio@gmail.com
01281129495
DR.Effat Abdl hady El tony, doctor
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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