Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

N/AUnknownNCT03204591

The Zhejiang Study Group for Organ Failure in Cirrhosis500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Cirrhosis, Liver Bacterial Infections Acute Liver Injury

Interventions

No interventionOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Occurrence of bacterial infection

Site,source, pathogen and severity

Time frame: Within 3 months from admission

Secondary Outcomes

28-day Mortality

Disease-associated mortality

Time frame: Within 28 days after enrollment

90-day Mortality