Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

NCT ID: NCT03204591

Last Updated: 2018-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-20

Study Completion Date

2019-01-18

Brief Summary

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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

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Conditions

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Cirrhosis, Liver Bacterial Infections Acute Liver Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LC with SALI

cirrhosis patients with severe acute liver injury

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ningbo No.2 Hospital

OTHER

Sponsor Role collaborator

The Zhejiang Study Group for Organ Failure in Cirrhosis

OTHER

Sponsor Role lead

Responsible Party

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Shi Yu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jifang Sheng, Doctor

Role: STUDY_CHAIR

Department of infectious disease, First Affiliated Hospital of Zhejiang University

Locations

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First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yu Shi, Doctor

Role: CONTACT

86-0571-87236489

Facility Contacts

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Hong Zhao, MD

Role: primary

Other Identifiers

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NSFC81670567

Identifier Type: -

Identifier Source: org_study_id

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