A Study of AARC Standards on Diagnosis and Treatment of Patients With HBV-ACLF in China (AARC China Study)

NCT04054037 | Unknown DMC

• 1 other identifier: AARC China Study
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure; HBV

Keywords

APASL ACLF Research Consortium; Diagnosis and treatment standard; HBV-ACLF; acute on chronic liver failure

Outcome Measures

Primary Outcomes (1)

• Non-liver transplant mortality

  Non-liver transplant mortality rate at 30 days, 90 days

  30 days, 90 days

Secondary Outcomes (1)

• progression of Chronic liver disease

  3 years

Study Arms (1)

HBV-ACLF Group

Patients with HBV related acute on chronic liver failure

Other: No intervention

Interventions

No intervention OTHER

This is an observation study, no intervention will be indicated during diagnosis and treatment.

HBV-ACLF Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HBV-related acute-on-chronic liver failure

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (1)

Department of Infectious Disease, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma will be restored in central lab

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure; Disease

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Qin Ning, MD., PhD.

  Department of Infectious Disease, Tongji Hospital

  STUDY DIRECTOR

Central Study Contacts

Qin Ning, MD., PhD.

CONTACT

0086 2783662391; qning@vip.sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director and Chair of Department of Infectious Diseases

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: August 13, 2019
• Study Start: July 2, 2019
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CN (1)