Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
SONIC
Prospective, Non-interventional, Multicenter Observational Study of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China
1 other identifier
observational
1,232
1 country
23
Brief Summary
This is a national, investigator-initiated, multicenter, prospective, observational, web-based registry in hospitalized patients with cirrhosis across China. The overarching aim of this study is to investigate the epidemiology and clinical impact of bacterial/fungal infections in hospitalized patients with liver cirrhosis in China within the collaborative network. We also aimed to build up the national prospective cohort of hospitalized cirrhosis in China to stand in the future for the backbone of various research programs focused on infection, other complications of cirrhosis, organ failure, the ACLF syndrome, end-stage liver disease and beyond.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 19, 2018
CompletedStudy Start
First participant enrolled
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedNovember 19, 2019
November 1, 2019
1.1 years
September 17, 2018
November 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
28-day transplantation-free Survival
Survival at 28-day follow-up without liver transplantation
From admission to 28-day post-admission
Secondary Outcomes (7)
Characteristics of bacterial/fungal infection including the prevalence of infection, the source of acquisition, type of infection, multidrug resistance rate, antibiotic treatment efficiency and efficacy in relation to disease course and outcome
From admission to discharge, an average of 28-day
Association between bacterial/fungal infection between other complications of cirrhosis、organ failure、AKI or ACLF.
From admission to discharge, an average of 28-day
Difference in type of organ failure between bacterial/fungal infection and other precipitating events.
From admission to discharge, an average of 28-day
ACLF and each sub-type organ failure development at 28-day
From admission to discharge, an average of 28-day
Transplantation-free Survival at 90-day
From admission to 90 day post-admission
- +2 more secondary outcomes
Study Arms (2)
Infection
Patients admitted or developed bacterial/fungal infection while hospitalization
Non-infection
Patients without bacterial/fungal infection
Eligibility Criteria
Hospitalized patients with cirrhosis evaluated in a dedicated and organized tertiary-care center (Liver Unit, Department of infectious diseases, Department of Gastroenterology, emergency department) across China.
You may qualify if:
- Inpatient with cirrhosis as confirmed either by the histological scoring system, imaging technique (abdominal Ultrasound, CT or MRI), endoscopic findings or a combination of biochemical and clinical manifestation.
- Admitted for at least one of the following reasons:
- Bacterial infection/fungal infection
- Overt Ascites (Grade II-III)
- Gastrointestinal bleeding
- Hepatic encephalopathy
- Jaundice (Total bilirubin ≥5 mg/dL) with coagulation dysfunction (INR ≥1.5)
You may not qualify if:
- \. Age below 16 or over 80 years
- \. Lactation/ Pregnancy women
- \. HIV infection
- \. Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugular intrahepatic portosystemic shunting, liver biopsy) or re-examination or multidisciplinary consultation)
- \. Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies
- \. Previous liver transplantation
- \. With previously known severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease; severe chronic pulmonary disease, psychiatric disorders)
- \. Taking immunosuppressive or anticoagulation drugs for the treatment of extra-hepatic disease.
- \. Patient' s refusal to participation
- \. Failure to provide prior informed consent or with documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (23)
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Department of Critical Care Medicine of Liver Disease, Beijing You'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Department of severe Liver Diseases, Fuzhou Municipal Infectious Disease Hospital, Mengchao Hepatobiliary Hospital of Fujian Medical University,
Fuzhou, Fujian, China
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China
Department of Infectious Disease, The First Hospital of Lanzhou University
Lanzhou, Gansu, China
The First People's Hospital of Lanzhou City
Lanzhou, Gansu, China
The Third People's Hospital of Guilin
Guilin, Guangxi, China
Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Department of Infectious Diseases, Third Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Department of Liver Diseases, The Third People's Hospital of Changzhou
Changzhou, Jiangsu, China
Department of Infectious Diseases, the Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China
The Fifth People's Hospital of Wuxi, Affiliated to Jiangnan University
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 201203, China
Department of Hepatology and Infection, Tongren Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University.
Xi’an, Shanxi, China
Department of Infectious Diseases, Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
The first Hospital of Jiaxing
Jiaxing, Zhejiang, 314000, China
Ningbo no.2 Hospital
Ningbo, Zhejiang, China
First Affiliated Hospital, Wenzhou Medical University
Wenzhou, Zhejiang, China
Biospecimen
Serum; Plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Xie, M.D., Ph.D.
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Department of Infectious diseases, Ruijin Hospital
Study Record Dates
First Submitted
September 17, 2018
First Posted
September 19, 2018
Study Start
November 7, 2018
Primary Completion
December 1, 2019
Study Completion
February 1, 2020
Last Updated
November 19, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share