{
  "abstract": "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China"
      ],
      "name": "Qianqian Li"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Huan Tong"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Digestive Disease Hospital, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China"
      ],
      "name": "Xuemei Liu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China"
      ],
      "name": "Fei Liao"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China"
      ],
      "name": "Han Ma"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Zhihang Zhou"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China"
      ],
      "name": "Fei Liu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China"
      ],
      "name": "Haitao Shi"
    },
    {
      "affiliations": [
        "Department of Hepatology, Infectious Diseases and Pathogen Biology Center, The First Hospital of Jilin University, Changchun, Jilin, China"
      ],
      "name": "Zhongfeng Wang"
    },
    {
      "affiliations": [
        "Department of Geriatrics, Yunnan Geriatric Medical Center, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China"
      ],
      "name": "Yang Sun"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China"
      ],
      "name": "Qunyan Yao"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, People’s Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Clinical Research Center for Digestive Diseases, Urumqi, Xinjiang, China"
      ],
      "name": "Yan Feng"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China"
      ],
      "name": "Ximei Li"
    },
    {
      "affiliations": [
        "Department of Hepatology, Shanxi Provincial People’s Hospital, The Fifth Hospital of Shanxi Medical University, Taiyuan, Shanxi, China"
      ],
      "name": "Jing Feng"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hainan General Hospital, Haikou, Hainan, China"
      ],
      "name": "Zhoutao He"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hunan Provincial People’s Hospital and the Affiliated Hunan Normal University, Changsha, Hunan, China"
      ],
      "name": "Ya Peng"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China"
      ],
      "name": "Zhaohui Bai"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Digestive Disease Hospital, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China"
      ],
      "name": "Rong Zhu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, Hubei, China"
      ],
      "name": "Du Cheng"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Zhejiang Provincial Clinical Research Center for Digestive Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China"
      ],
      "name": "Chengfu Xu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Song He"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China"
      ],
      "name": "Huihong Yu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China"
      ],
      "name": "Chen Xie"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China"
      ],
      "name": "Jia Yuan"
    },
    {
      "affiliations": [
        "Department of Hepatology, Infectious Diseases and Pathogen Biology Center, The First Hospital of Jilin University, Changchun, Jilin, China"
      ],
      "name": "Xinrui Wang"
    },
    {
      "affiliations": [
        "Department of Geriatrics, Yunnan Geriatric Medical Center, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China"
      ],
      "name": "Hongju Yang"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China"
      ],
      "name": "Yanting Zou"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Zhongshan Hospital, Fudan University, Shanghai, China"
      ],
      "name": "Shuyu Li"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, People’s Hospital of Xinjiang Uygur Autonomous Region, Xinjiang Clinical Research Center for Digestive Diseases, Urumqi, Xinjiang, China"
      ],
      "name": "Ting Li"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, People’s Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China"
      ],
      "name": "Shengjuan Hu"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hainan General Hospital, Haikou, Hainan, China"
      ],
      "name": "Chaochao Chen"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hunan Provincial People’s Hospital and the Affiliated Hunan Normal University, Changsha, Hunan, China"
      ],
      "name": "Zhiyuan Chen"
    },
    {
      "affiliations": [
        "Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, The Netherlands"
      ],
      "name": "Marten A Lantinga"
    },
    {
      "affiliations": [
        "Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy"
      ],
      "name": "Mauro Bernardi"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, Liaoning, China"
      ],
      "name": "Xingshun Qi"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, Sichuan, China"
      ],
      "name": "Chengwei Tang"
    },
    {
      "affiliations": [],
      "name": "On the behalf of Young Member Group of Chinese Gastroenterology Society"
    }
  ],
  "title": "Human Albumin infusion in liver Cirrhosis and overt Hepatic Encephalopathy (HACHE): protocol of an investigator-initiated, open-label, multicentre, randomised controlled trial",
  "uid": "566825a8-f8ea-596e-8f37-a811c47ca70d"
}