BMJ open · 2025
Human Albumin infusion in liver Cirrhosis and overt Hepatic Encephalopathy (HACHE): protocol of an investigator-initiated, open-label, multicentre, randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Li Qianqian, Tong Huan, Liu Xuemei, Liao Fei, Ma Han, Zhou Zhihang, Liu Fei, Shi Haitao, Wang Zhongfeng, Sun Yang, Yao Qunyan, Feng Yan, Li Ximei, Feng Jing, He Zhoutao, Peng Ya, Bai Zhaohui, Zhu Rong, Cheng Du, Xu Chengfu, He Song, Yu Huihong, Xie Chen, Yuan Jia, Wang Xinrui, Yang Hongju, Zou Yanting, Li Shuyu, Li Ting, Hu Shengjuan, Chen Chaochao, Chen Zhiyuan, Lantinga Marten A, Bernardi Mauro, Qi Xingshun, Tang Chengwei, On the behalf of Young Member Group of Chinese Gastroenterology Society
Аннотация
INTRODUCTION: Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterised as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, we planned a randomised controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in patients with liver cirrhosis and overt HE.
METHODS AND ANALYSIS: This RCT will be conducted in the Departments of Gastroenterology or Hepatology of 16 tertiary hospitals in China. Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE and a serum albumin level of 23-30 g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary end point is the improvement of overt HE within 3-5 days after treatment. The secondary end points include recurrence of overt HE, survival and adverse events. We expect that this RCT will provide high-quality evidence on the optimal dosage of human albumin infused, which can achieve more clinical benefits to patients with liver cirrhosis and overt HE.
ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethical Committee of the General Hospital of Northern Theater Command (ethical approval number Y2024-148). The study findings will be published in academic journals.
TRIAL REGISTRATION NUMBER: NCT06483737.
METHODS AND ANALYSIS: This RCT will be conducted in the Departments of Gastroenterology or Hepatology of 16 tertiary hospitals in China. Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE and a serum albumin level of 23-30 g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary end point is the improvement of overt HE within 3-5 days after treatment. The secondary end points include recurrence of overt HE, survival and adverse events. We expect that this RCT will provide high-quality evidence on the optimal dosage of human albumin infused, which can achieve more clinical benefits to patients with liver cirrhosis and overt HE.
ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethical Committee of the General Hospital of Northern Theater Command (ethical approval number Y2024-148). The study findings will be published in academic journals.
TRIAL REGISTRATION NUMBER: NCT06483737.