NCT04790435

Brief Summary

Cirrhosis is a condition characterized by diffuse fibrosis, severe disruption of the intrahepatic arterial and venous flow, portal hypertension and, ultimately, liver cell failure. Traditionally, cirrhosis has been dichotomised in compensated and decompensated, and the transition to decompensated cirrhosis happens when any of the following hallmarks occurs: presence of ascites, variceal haemorrhage and/ or hepatic encephalopathy (HE) . In Egypt, HCV is the main cause of liver cirrhosis followed by HBV

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 1, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 16, 2022

Status Verified

May 1, 2022

Enrollment Period

11 months

First QC Date

March 1, 2021

Last Update Submit

May 12, 2022

Conditions

Keywords

Cirrhosis, liver failure

Outcome Measures

Primary Outcomes (1)

  • Predictors of 28 day mortality rate in acute on chronic liver failure patients. with acute on top of chronic liver failure

    It will be determined by univariate and multivariate analysis.

    4 weeks from start point.

Secondary Outcomes (2)

  • Triggers of development of ACLF .

    4 weeks from start point.

  • Types and numbers of organ failures in patients with ACLF.

    4 weeks from start point

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cirrhotic patients whether compensated or decompensated with an acute decompensation of cirrhosis which is defined by the recent development of ascites, encephalopathy, GI haemorrhage, bacterial infection, or any combination of these

You may qualify if:

  • Cirrhotic patients whether compensated or decompensated with an acute decompensation of cirrhosis which is defined by the recent development of ascites, encephalopathy, GI haemorrhage, bacterial infection, or any combination of these

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Liver CirrhosisFibrosisLiver Failure

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHepatic Insufficiency

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Tropical Medicine and Gastroenterology Department

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 10, 2021

Study Start

March 1, 2021

Primary Completion

February 1, 2022

Study Completion

February 1, 2022

Last Updated

May 16, 2022

Record last verified: 2022-05

Locations