Li Zhipeng, Luo Qiumin, Wang Peipei, Wang Lu, Zheng Xingrong, Zhang Yeqiong, Xu Wenxiong, Peng Liang
Department of Infectious Diseases, Third Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China.
Department of Diagnostics, Second School of Clincal Medicine, Binzhou Medical College, Yantai, Shandong, China.
BMJ Open. 2024 Dec 9;14(12):e088832. doi: 10.1136/bmjopen-2024-088832.
Malnutrition is a common complication of hepatitis B virus-related acute-on-chronic liver failure (HBV-ACLF) typically associated with poor prognosis. Despite nutritional treatment, the outcomes for these patients are limited by the symptoms and complications associated with ACLF. So far, the benefits of nutritional interventions in these populations have not been proven. This study aims to explore a new nutritional intervention method for patients with HBV-ACLF and evaluate its safety and efficacy.
This study is an investigator-initiated, nonblind, randomised controlled clinical trial. We will recruit 60 patients with HBV-ACLF according to the Chinese Group on the Study of Severe Hepatitis B criteria hospitalised in the Infectious Diseases Department of the Third Affiliated Hospital of Sun Yat-Sen University. Eligible patients will be randomly allocated to the nutrition support group (intervention group) and the control group in a 1:1 ratio. Patients in the nutrition support group will receive 10 days of tailor-made nutrition therapy consisting of oral nutritional supplements and supplementary parenteral nutrition. Patients in the control group will receive standard nutrition with dietary advice. All assessments will be conducted at baseline, 30 days and 90 days. The primary outcome measure is the liver transplant-free mortality rate. The secondary indicators include the incidence of clinical adverse outcomes and changes in indicators such as muscle mass, muscle strength, physical function and quality of life (EQ-5D scale).
This study has been approved by the Medical Ethics Committee of the Third Affiliated Hospital of Sun Yat-Sen University (approval number: II2023-242-03). The results and conclusions of the clinical trial will be published in academic conferences or journals.
NCT06128421.
营养不良是乙型肝炎病毒相关慢加急性肝衰竭（HBV-ACLF）的常见并发症，通常与预后不良相关。尽管进行了营养治疗，但这些患者的治疗效果仍受ACLF相关症状和并发症的限制。到目前为止，营养干预对这些人群的益处尚未得到证实。本研究旨在探索一种针对HBV-ACLF患者的新型营养干预方法，并评估其安全性和有效性。
本研究是一项由研究者发起的、非盲法、随机对照临床试验。我们将根据《中国重型乙型肝炎研究组标准》，招募60例在中山大学附属第三医院感染科住院的HBV-ACLF患者。符合条件的患者将按1:1的比例随机分配至营养支持组（干预组）和对照组。营养支持组的患者将接受为期10天的定制营养治疗，包括口服营养补充剂和补充肠外营养。对照组的患者将接受标准营养及饮食建议。所有评估将在基线、30天和90天时进行。主要结局指标是无肝移植死亡率。次要指标包括临床不良结局的发生率以及肌肉量、肌肉力量、身体功能和生活质量（EQ-5D量表）等指标的变化。
本研究已获得中山大学附属第三医院医学伦理委员会批准（批准文号：II2023-242-03）。临床试验的结果和结论将在学术会议或期刊上发表。
NCT06128421。
