Efficacy and safety of individual nutrition support in patients with hepatitis B virus-related acute-on-chronic liver failure at nutrition risk: a study protocol for a randomised controlled clinical trial.

Introduction: 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.

Methods And Analysis: 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).

Ethics And Dissemination: 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.

Trial Registration Number: NCT06128421.