Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure (PGE2)

A Study on Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure

Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic inflammation and alleviate liver injury in mice model. However, there are no studies evaluating PGE2 as a predictor of early mortality.This study is designed to investigate whether plasma PGE2 and its receptors are associated with development of MOF and predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we will also measure several other potential predictive factors (C-reactive protein,severe hyponatremia, Second infections,Diabetes mellitus,High density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).

Study Overview

• Status: Completed
• Conditions: Acute-On-Chronic Liver Failure; Cirrhosis and Chronic Liver Disease
• Intervention / Treatment: Diagnostic test: plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.

• Study Type: Observational
• Enrollment (Actual): 350

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The cohorts will be selected from Provincial General Hospital

Description

Inclusion Criteria:

• Clinical diagnosis of acute-on-chronic liver failure according to Asian-Pacific Association for the Study of the Liver (APASL) diagnostic criteria

Exclusion Criteria:

• Hepatocellular carcinoma(HCC)
• Portal vein thrombosis
• Pregnancy
• Human immunodeficiency virus (HIV)
• Patients who had received immunomodulator,or cytotoxic/immunosuppressive therapy within at least the preceding 12 months

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
HC,CHB,AD,ACLF; HC healthy controls; CHB chronic hepatitis B; AD acute decompensated cirrhosis; ACLF acute-on-chronic liver failure.	Diagnostic test: plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality	90 days
incidence of multiorgan failure	90 days
all cause mortality	30 days

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Publications and helpful links

General Publications

• Wang Y, Wu F, Chen C, Xu L, Lin W, Huang C, Yang Y, Wu S, Qi J, Cao H, Li G, Hong M, Zhu H. Soluble urokinase plasminogen activator receptor is associated with short-term mortality and enhanced reactive oxygen species production in acute-on-chronic liver failure. BMC Gastroenterol. 2021 Nov 17;21(1):429. doi: 10.1186/s12876-021-02006-x.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2016
• Primary Completion (Actual): October 10, 2017
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (Estimate): November 16, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 3, 2018
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure, Acute; Liver Diseases; End Stage Liver Disease; Liver Failure; Hepatic Insufficiency; Acute-On-Chronic Liver Failure
• Other Study ID Numbers: tclouds