Intensive goal-directed nutritional management improves outcomes in HBV related ACLF patients: a randomized controlled trial

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Background & Aims Patients with acute-on-chronic liver failure (ACLF) are at high nutritional risk, which adversely influences prognosis. However, evidence supporting nutritional therapies in this population remains limited. We aimed to assesses the safety and efficacy of intensive, goal-directed nutritional management in HBV-related ACLF (HBV-ACLF). Methods In this open-label, randomized controlled trial, 80 HBV-ACLF patients with Nutritional Risk Screening 2002 score ≥ 3 were randomized to receive either intensive goal-directed nutritional management (energy: 1.2×resting energy expenditure; protein: 1.2 g/kg/day, delivered through a stepwise protocol) or standard dietary advice. Primary endpoints were 30- and 90-day transplant-free mortality; secondary endpoints included safety, adverse clinical outcomes, liver severity scores, anthropometry, muscle function and quality of life. Results The modified intention-to-treat analysis included 78 patients (39 in each group). Compared with controls, intervention group reduced transplant-free mortality at day 30 (2.6% vs 20.5%) and day 90 (18.0% vs 38.5%), p = 0.030. In adjusted analyses, the survival benefit showed a consistent direction (adjusted HR 0.412, 95% CI 0.161–1.051, p = 0.063). The incidence of adverse clinical outcomes was lower in the intervention group at day 30 (23.7% vs 45.2%, p = 0.060) and day 90 (21.9% vs 70.8%, p < 0.001). The intervention group exhibited a more pronounced improvement in MELD score, COSSH-ACLF II score, anthropometric parameters, muscle function, and EQ-5D scores compared with controls (p < 0.05 for most comparisons). Conclusions Intensive goal-directed nutritional management improved short-term transplant-free mortality, hepatic function, muscle performance and quality of life in nutritionally at-risk HBV-ACLF patients. ACLF care may benefit from early, goal-directed nutritional intervention.