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

Acute-On-Chronic Liver Failure Clinical Trial

— PGE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02965560
• Other study ID #: tclouds
• Status: Completed
• Start date: October 10, 2016
• Est. completion date: June 1, 2018

Study information

• Verified date: October 2016
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: June 1, 2018
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Chronic Disease
• Cirrhosis and Chronic Liver Disease
• End Stage Liver Disease
• Liver Cirrhosis
• Liver Diseases
• Liver Failure

Intervention

Diagnostic Test:
• plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		90 days
Primary	incidence of multiorgan failure		90 days
Primary	all cause mortality		30 days