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

Completed

• Conditions: Cirrhosis and Chronic Liver Disease; Acute-On-Chronic Liver Failure
• Interventions: Diagnostic Test: plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.

• Registration Number: NCT02965560
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study Start: 2016-10-10
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-16
• Primary Completion: 2017-10-10
• Study Completion: 2018-06-01
• Last Update Submitted: 2018-06-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
all cause mortality	30 days
incidence of multiorgan failure	90 days