NCT02965560

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 6, 2018

Status Verified

October 1, 2016

Enrollment Period

1 year

First QC Date

November 14, 2016

Last Update Submit

June 3, 2018

Conditions

Outcome Measures

Primary Outcomes (3)

  • all cause mortality

    90 days

  • incidence of multiorgan failure

    90 days

  • all cause mortality

    30 days

Study Arms (1)

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.

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The cohorts will be selected from Provincial General Hospital

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureFibrosis

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 16, 2016

Study Start

October 10, 2016

Primary Completion

October 10, 2017

Study Completion

June 1, 2018

Last Updated

June 6, 2018

Record last verified: 2016-10