An observational study in Cirrhosis, sponsored by Ruijin Hospital. Status unknown at 23 sites in China. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-11-19.
Sponsored by Ruijin Hospital · Observational
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.
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.
3,274 studies on the registry are indexed under Fibrosis; 466 are open to participants now.
This study's planned enrollment of 1,232 is above the median of 112 across 984 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Ruijin Hospital is the lead sponsor of 667 studies on the registry; 376 are open to participants now.
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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.
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Admitted for at least one of the following reasons:
Exclusion Criteria:
Patients admitted or developed bacterial/fungal infection while hospitalization
Patients without bacterial/fungal infection
28-day transplantation-free Survival
Survival at 28-day follow-up without liver transplantation
Time frame: From admission to 28-day post-admission
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
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
Time frame: From admission to discharge, an average of 28-day
Association between bacterial/fungal infection between other complications of cirrhosis、organ failure、AKI or ACLF.
Association between bacterial/fungal infection between other complications of cirrhosis、organ failure、AKI or ACLF.
Time frame: From admission to discharge, an average of 28-day
Difference in type of organ failure between bacterial/fungal infection and other precipitating events.
Difference in type of organ failure between bacterial/fungal infection and other precipitating events.
Time frame: From admission to discharge, an average of 28-day
ACLF and each sub-type organ failure development at 28-day
ACLF defined as per EASL CLIF-C or NACSELD definition Organ failure defined as per CLIF-C OF criteria, including Liver, coagulation, kidney, brain, respiratory and circulatory.
Time frame: From admission to discharge, an average of 28-day
Transplantation-free Survival at 90-day
Survival at 90-day follow-up without liver transplantation
Time frame: From admission to 90 day post-admission
Overall survival at 28-、90-day
Overall survival at 28-、90-day
Time frame: From admission to 90 day post-admission
Readmission and further decompensations rate at 90-day post discharge
Readmission and further decompensations rate at 90-day post discharge
Time frame: From admission to 90 day post-discharge
Plan to share: No
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This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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