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Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

Risk of Bacterial Infection in Cirrhotic Patients With Acute Severe Liver Injury: a Multicenter,Prospective, Observational Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03204591
Enrollment
500
Registered
2017-07-02
Start date
2017-07-20
Completion date
2019-01-18
Last updated
2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Liver Injury, Bacterial Infections, Cirrhosis, Liver

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

Ningbo No.2 Hospital
CollaboratorOTHER
The Zhejiang Study Group for Organ Failure in Cirrhosis
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of bacterial infectionWithin 3 months from admissionSite,source, pathogen and severity

Secondary

MeasureTime frameDescription
28-day MortalityWithin 28 days after enrollmentDisease-associated mortality
90-day MortalityWithin 90 days after enrollmentDisease-associated mortality

Countries

China

Contacts

Primary ContactYu Shi, Doctor
zjushiyu@zju.edu.cn86-0571-87236489

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026