Status:
UNKNOWN
A Study of AARC Standards on Diagnosis and Treatment of Patients With HBV-ACLF in China (AARC China Study)
Lead Sponsor:
Qin Ning
Conditions:
Acute on Chronic Liver Failure
HBV
Eligibility:
All Genders
Brief Summary
The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.
Detailed Description
Acute on chronic liver failure (ACLF) is a clinically critical illness and has been extensively researched around the world. However, there is a potential "communication barrier" in the ACLF study; th...
Eligibility Criteria
Inclusion
- Chronic liver disease: Chronic hepatitis B
- Acute deterioration of liver function: more than one of the below criteria
- development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria)
- development of hepatic encephalopathy
- development of gastrointestinal hemorrhage
- development of jaundice (serum bilirubin greater than or equal to 3mg/dl)
- development of bacterial infection
- spontaneous bacteremia: positive blood cultures without a source of infection
- spontaneous bacterial peritonitis: ascitic fluid polymorphonuclear cells \>250/µL
- lower respiratory tract infections: new pulmonary infiltrate in the presence of: i) at least one respiratory symptom (cough, sputum production, dyspnea, pleuritic pain) with ii) at least one finding on auscultation (rales or crepitation) or one sign of infection (core body temperature \>38\_C or less than 36\_C, shivering, or leukocyte count \>10,000/mm3 or \<4,000/mm3) in the absence of antibiotics
- Clostridium difficile Infection: diarrhea with a positive C. difficile assay
- bacterial entero-colitis: diarrhea or dysentery with a positive stool culture for Salmonella, Shigella, Yersinia, Campylobacter, or pathogenic E. coli;
- soft-tissue/skin Infection: fever with cellulitis
- urinary tract infection (UTI): urine white blood cell \>15/high-power field with either positive urine gram stain or culture;
- intra-abdominal infections: diverticulitis, appendicitis, cholangitis, etc.
- other infections not covered above;
- fungal infections as a separate category.
Exclusion
- Patients who do not have chronic liver disease
- Patients who have hepatocellular carcinoma
- Patients who admitted for extrahepatic manifestations
- Patients who have HIV infection
- Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
Key Trial Info
Start Date :
July 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04054037
Start Date
July 2 2019
End Date
April 1 2023
Last Update
August 13 2019
Active Locations (1)
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1
Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030