Bacterial Infections in Cirrhotic Patients With Acute Severe Liver Injury

Bacterial Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03204591
• Other study ID #: NSFC81670567
• Status: Recruiting
• Start date: July 20, 2017
• Est. completion date: January 18, 2019

Study information

• Verified date: June 2018
• Source: The Zhejiang Study Group for Organ Failure in Cirrhosis
• Contact: Yu Shi, Doctor
• Phone: 86-0571-87236489
• Email: zjushiyu[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 18, 2019
• Est. primary completion date: October 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Liver Injury
• Bacterial Infections
• Cirrhosis, Liver
• Communicable Diseases
• Infection
• Liver Cirrhosis
• Wounds and Injuries

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
The Zhejiang Study Group for Organ Failure in Cirrhosis	Ningbo No.2 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of bacterial infection	Site,source, pathogen and severity	Within 3 months from admission
Secondary	28-day Mortality	Disease-associated mortality	Within 28 days after enrollment
Secondary	90-day Mortality	Disease-associated mortality	Within 90 days after enrollment