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

Shanghai Jiao Tong University

Status

Unknown

Conditions

Cirrhosis

Study type

Observational

Funder types

Other

Identifiers

NCT03676777

SONIC

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,232 estimated patients

Sex

All

Ages

16 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
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 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, transjugular intrahepatic portosystemic shunting, liver biopsy) or re-examination or multidisciplinary consultation)
1. Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies
1. Previous liver transplantation
1. With previously known severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease; severe chronic pulmonary disease, psychiatric disorders)
1. Taking immunosuppressive or anticoagulation drugs for the treatment of extra-hepatic disease.
1. Patient' s refusal to participation
1. 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