An Observational Study of Risk Factors and Long-term Prognosis of Patients With Liver Abscess in the "Real-world"

Infections Clinical Trial

Official title:

An Observational Study of Risk Factors and Long-term Prognosis of Patients With Pyogenic Liver Abscess in the "Real-world"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05213949
• Other study ID #: NFEC-2021-355
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: August 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xuyen Xu, MD
• Phone: 020-62786539
• Email: xuxuwen95[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years of age;
• Irrespective of gender;
• Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan.

Exclusion Criteria:

• Patients <18 years old;
• Pregnancy at presentation.

Related Conditions & MeSH terms

• Abscess
• Infections
• Liver Abscess
• Liver Abscess, Pyogenic

Locations

Country	Name	City	State
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion and causes of deaths within 2 years of discharge from hospital	Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.	2 years
Primary	Proportion and causes of re-hospitalization within 2 years of discharge from hospital	Define the proportion and causes of re-hospitalization within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses.	2 years
Secondary	The recurrence rate of pyogenic liver abscess	Development new liver abscess after clinical cure during the 2 years follow up period	2 years
Secondary	The number of participants with Histological Change in the Liver	Assessment of histological change in the liver by using ultrasonography or transient elastography during the 2 years follow up period	2 years