Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in China

Last updated: November 17, 2019
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Fibrosis

Liver Disorders

Liver Disease

Treatment

N/A

Clinical Study ID

NCT03676777
SONIC
  • Ages 16-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Inpatient with cirrhosis as confirmed either by the histological scoring system,imaging technique (abdominal Ultrasound, CT or MRI), endoscopic findings or acombination of biochemical and clinical manifestation.

  • Admitted for at least one of the following reasons:

  1. Bacterial infection/fungal infection

  2. Overt Ascites (Grade II-III)

  3. Gastrointestinal bleeding

  4. Hepatic encephalopathy

  5. Jaundice (Total bilirubin ≥5 mg/dL) with coagulation dysfunction (INR ≥1.5)

Exclusion

Exclusion Criteria:

    1. Age below 16 or over 80 years
    1. Lactation/ Pregnancy women
    1. HIV infection
    1. Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugularintrahepatic portosystemic shunting, liver biopsy) or re-examination ormultidisciplinary consultation)
    1. Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminatedmalignancies
    1. Previous liver transplantation
    1. With previously known severe extra-hepatic diseases (e.g., chronic renal failurerequiring hemodialysis, severe heart disease; severe chronic pulmonary disease,psychiatric disorders)
    1. Taking immunosuppressive or anticoagulation drugs for the treatment ofextra-hepatic disease.
    1. Patient' s refusal to participation
    1. Failure to provide prior informed consent or with documented evidence that thepatient has no legal surrogate decision maker and it appears unlikely that the patientwill regain consciousness or sufficient ability to provide delayed informed consent

Study Design

Total Participants: 1232
Study Start date:
November 07, 2018
Estimated Completion Date:
February 29, 2020

Study Description

Patients with cirrhosis are prone to infections due to the abnormal bacterial translocation and immune dysfunction. Infections are more common when these patients are admitted into the hospital. Infections are life-threatening complications of cirrhosis which can precipitate hepatic encephalopathy, acute kidney injury, and the acute-on-chronic liver failure (ACLF) syndrome. The survival rate is significantly decreased once infections set in, especially when the first-line empirical antibiotic therapy is insufficient or inappropriate. Moreover, the prevalence of multi-drug-resistant organism (MDRO) is naturally increasing across the world due to the overuse of antibiotics. Patients with cirrhosis, especially those at the decompensated stage are at high risk of developing MDRO due to recurrent hospitalizations and repeatedly exposed to antibiotics either for treatment or prophylactic purposes. Empiric antibiotic therapy could be very difficult without understanding the profile of antibiotic resistance and could be varied significantly among different areas.

The issue of infection in patients with cirrhosis has been recently highlighted by International Club of Ascites with its "GLOBAL" study (ILC2018, GS-001) showing that the global prevalence of MDRO across the world was 34% (95% CI=31-37%). The prevalence of MDRO varies across the world with the highest in India followed by South America and other Asian countries. The source of acquisition (Community acquire, health-care related or nosocomial origin), site of infection (Spontaneous bacterial peritonitis, urinary tract, blood, respiratory tract, etc.) and category of the organism (Gram negative or positive) had an influence on the prevalence of MDRO and response to empirical antibiotic treatment. The results highlight the need to develop different empirical antibiotic strategies across different continents and countries, although China was not included in this study. Epidemiology data and investigation on the role of bacterial/fungal infection in patients with cirrhosis from China is therefore urgently needed.

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.

Connect with a study center

  • First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui
    China

    Active - Recruiting

  • Department of Critical Care Medicine of Liver Disease, Beijing You'an Hospital, Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

  • Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Department of severe Liver Diseases, Fuzhou Municipal Infectious Disease Hospital, Mengchao Hepatobiliary Hospital of Fujian Medical University,

    Fuzhou, Fujian
    China

    Active - Recruiting

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen, Fujian
    China

    Active - Recruiting

  • Department of Infectious Disease, The First Hospital of Lanzhou University

    Lanzhou, Gansu
    China

    Active - Recruiting

  • The First People's Hospital of Lanzhou City

    Lanzhou, Gansu
    China

    Active - Recruiting

  • The Third People's Hospital of Guilin

    Guilin, Guangxi
    China

    Active - Recruiting

  • Department of Infectious Disease, The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi
    China

    Active - Recruiting

  • Department of Infectious Diseases, Third Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Department of Liver Diseases, The Third People's Hospital of Changzhou

    Changzhou, Jiangsu
    China

    Active - Recruiting

  • Department of Infectious Diseases, the Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • The Fifth People's Hospital of Wuxi, Affiliated to Jiangnan University

    Wuxi, Jiangsu
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Department of Cirrhosis, Institute of Liver Disease, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai 201203
    China

    Active - Recruiting

  • Department of Hepatology and Infection, Tongren Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University.

    Xi'an, Shanxi
    China

    Active - Recruiting

  • Department of Infectious Diseases, Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • The first Hospital of Jiaxing

    Jiaxing, Zhejiang 314000
    China

    Active - Recruiting

  • Ningbo no.2 Hospital

    Ningbo, Zhejiang
    China

    Active - Recruiting

  • First Affiliated Hospital, Wenzhou Medical University

    Wenzhou, Zhejiang
    China

    Active - Recruiting

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