NCT06142968

Brief 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Dec 2023

Typical duration for all trials

Status
not yet recruiting

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

Study Progress86%
Dec 2023Oct 2026

First Submitted

Initial submission to the registry

September 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1 month

First QC Date

September 14, 2023

Last Update Submit

November 18, 2023

Conditions

Outcome Measures

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.

    baseline

Secondary Outcomes (1)

  • ACLF score ( acute on chronic liver failure score )

    baseline

Interventions

laboratory testsDIAGNOSTIC_TEST

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

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with liver cirrhosis

You may qualify if:

  • 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 )

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

Related Links

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Clinical Laboratory Techniques

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Nardin Nadi Roshdy Saweres, Master

CONTACT

DR.Effat Abdl hady El tony, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle invistegator

Study Record Dates

First Submitted

September 14, 2023

First Posted

November 22, 2023

Study Start

December 1, 2023

Primary Completion

January 1, 2024

Study Completion (Estimated)

October 1, 2026

Last Updated

November 22, 2023

Record last verified: 2023-11