Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

NCT03204591 | Unknown DMC

• 1 other identifier: NSFC81670567
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Acute hepatic insults including hepatitis flare-up, active alcohol assumption and hepatotoxic drug use are common in patients with cirrhosis especially in Eastern countries.These patients are at high risk of developing acute-on-chronic liver failure (ACLF) and associated with high short-term mortality. And the natural history of these patients is frequently complicated by bacterial infections, which lead to deterioration of underlying diseases. The present study is aimed to investigate the prevalance and risk factors of bacterial infections in those patients and its impact on in-hospital/short-term mortality.

Conditions

Cirrhosis, Liver; Bacterial Infections; Acute Liver Injury

Outcome Measures

Primary Outcomes (1)

• Occurrence of bacterial infection

  Site,source, pathogen and severity

  Within 3 months from admission

Secondary Outcomes (2)

• 28-day Mortality

  Within 28 days after enrollment

• 90-day Mortality

  Within 90 days after enrollment

Study Arms (1)

LC with SALI

cirrhosis patients with severe acute liver injury

Other: No intervention

Interventions

No intervention OTHER

No intervention

LC with SALI

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cirrhosis of any etiology who had acute severe liver injury

You may qualify if:

• The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
• Flare up of acute severe liver injury within one month before enrollment. Acute severe liver injury is defined as: increase of serum bilirubin \>=85mmol/L and international normalized ratio (INR)\>=1.5 with a definite hepatic insult.

You may not qualify if:

• (1)pregnancy; (2) disseminated maliganancy; (3)previously received a liver transplant; (4) HIV infection;

Sponsors & Collaborators

• The Zhejiang Study Group for Organ Failure in Cirrhosis: lead
• Ningbo No.2 Hospital: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Bacterial Infections

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Infections

Study Officials

• Jifang Sheng, Doctor

  Department of infectious disease, First Affiliated Hospital of Zhejiang University

  STUDY CHAIR

Central Study Contacts

Yu Shi, Doctor

CONTACT

86-0571-87236489; zjushiyu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 2, 2017
• Study Start: July 20, 2017
• Primary Completion: October 18, 2018
• Study Completion: January 18, 2019
• Last Updated: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)