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

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.

Conditions

• Acute on Chronic Liver Failure
• Traditional Chinese Medicine
• Hepatitis B

Interventions

DRUG

Chinese herbal medicine

One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.

OTHER

Control (blank)

SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.

Sponsors & Collaborators

• Beijing YouAn Hospital

  collaborator OTHER

• ShuGuang Hospital

  collaborator OTHER

• Sun Yat-sen University

  collaborator OTHER

• Huazhong University of Science and Technology

  collaborator OTHER

• Fuzhou Infectious Hospital

  collaborator UNKNOWN

• The Sixth People's Hospital of Shenyang

  collaborator OTHER

• Public Health Clinical Center of Chengdu

  collaborator UNKNOWN

• Hepatology hospital of Jilin Province

  collaborator UNKNOWN

• Shanghai Public Health Clinical Center

  collaborator OTHER_GOV

• Guangxi University of Chinese Medicine

  collaborator UNKNOWN

• Hubei Hospital of Traditional Chinese Medicine

  collaborator OTHER

• Beijing Ditan Hospital

  collaborator OTHER

• Shenzhen traditional Chinese medical hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

  collaborator OTHER

• Shenzhen Third People's Hospital

  collaborator OTHER

• Tianjin Second People's Hospital

  collaborator OTHER

• Hangzhou Xixi hospital

  collaborator UNKNOWN

• Beijing 302 Hospital

  lead OTHER

Principal Investigators

• Man Gong, Doctor · Beijing 302 Hospital

• Kewei Sun · The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

• Zhengfang Liu · Fuzhou Infectious Hospital

• Jiefei Wang · Shanghai Public Health Clinical Center

• Yunhui Zhuo · Shuguang Hospital of Shanghai University of Traditional Chinese Medicine

• Shuqin Zhang · Jilin hematology hospital

• Wukui Cao · Tianjin Second People's Hospital

• Zhengang Zhang · Tongji Hospital

• Lin Wang · Chengdu Public Health Clinical Center

• Ye Gu · The Sixth People's Hospital of Shenyang

• Jianchun Guo · Hangzhou Xixi hospital

• Xianbo Wang · Beijing Ditan Hospital

• Xiuhui Li · Beijing YouAn Hospital

• Xiaozhou Zhou · Affiliated Hospital of Nanjing University of Chinese Medicine

• Jinmo Tang · Xiamen Hospital of Traditional Chinese Medicine

• Hanmin Li · Hubei traditional Chinese medicine hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-01-10

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• China

Study Locations