Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

• Conditions: Bacterial Infections; Acute Liver Injury; Cirrhosis, Liver
• Interventions: Other: No intervention

• Registration Number: NCT03204591
• Lead Sponsor: The Zhejiang Study Group for Organ Failure in Cirrhosis

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-27
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Study Start: 2017-07-20
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06
• Primary Completion: 2018-10-18
• Study Completion: 2019-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. The presence of cirrhosis confirmed by liver biopsy, endoscopy, radiological examination, or clinical evidence of prior hepatic de-compensation;
2. 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.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LC with SALI	No intervention	cirrhosis patients with severe acute liver injury

Primary Outcome Measures

Name	Time	Method
Occurrence of bacterial infection	Within 3 months from admission	Site,source, pathogen and severity

Secondary Outcome Measures

Name	Time	Method
28-day Mortality	Within 28 days after enrollment	Disease-associated mortality
90-day Mortality	Within 90 days after enrollment	Disease-associated mortality

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China