Study on the Optimal Strategy for Acute-on-chronic Liver Failure With Integrative Treatment

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

Summary

Background: Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration in the setting of chronic liver disease associated with high short-term mortality. Currently, there is no specific treatment for patients with ACLF. Our previous results showed that Chinese herbal medicine (CHM) could reduce the mortality rate and the incidence of complications of ACLF effectively. In this study, we aim to conduct the multi-center randomized controlled trial to evaluate the effect of unified CHM formulas and provide propagable and high-level evidence for clinical practice.

Methods/design: This is a prospective, multicenter, centrally randomized controlled trial. Five hundred and ten patients diagnosed with HBV-related ACLF will be allocated in a 1:1 ratio to SMT group (standard medical therapy) and CHM group (CHM and SMT). The primary outcome is the transplant-free mortality rates at week 4, 8, 12, 24 and 48. Secondary outcomes include (1) the incidence of adverse reactions, (2) influence on liver function, (3) the incidence of serious complications and (4) the level of inflammatory cytokines.

Discussion: The effectiveness and safety of CHM formulas are assessed in the treatment of ACLF.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beijing 302 Hospital
• Collaborators: Beijing Ditan Hospital; Beijing YouAn Hospital; Fuzhou Infectious Hospital; Guangxi University of Chinese Medicine; Hangzhou Xixi hospital; Hepatology hospital of Jilin Province; Huazhong University of Science and Technology; Hubei Hospital of Traditional Chinese Medicine; Public Health Clinical Center of Chengdu; Shanghai Public Health Clinical Center; Shenzhen Third People's Hospital; Shenzhen traditional Chinese medical hospital; ShuGuang Hospital; Sun Yat-sen University; The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine; The second people's hospital of Tianjin; The Sixth People's Hospital of Shenyang; Tianjin Second People's Hospital

Criteria

Inclusion Criteria:

• In-patients with acute-on-chronic liver failure;

• Patients with chronic hepatitis B or compensatory cirrhosis of hepatitis B;

• Patients who is willing to sign the informed consent;

• Patients aged among 16~65 years old.

Exclusion Criteria:

• Acute liver failure, or sub acute liver failure, or chronic liver failure;

• Acute-on-chronic liver failure not caused by hepatitis B but other disease such as autoimmune, drug, alcohol, toxic, parasites;

• Pregnant or lactating women;

• Primary liver cancer;

• Combined with other severe systematic disease and mental disease;

• Anti-HIV positive or combined with infection of hepatitis A, C, D, E virus or cytomegalovirus, Epstein-Barr virus;

• Enrolled in other clinical studies in last three months;

• Person unwilling to cooperate; 9. poor compliance, unable guarantee completing the protocol;

• Complicated with severe cerebral edema, severe infection, type I liver-kidney symptom, and gastrointestinal hemorrhage.