Outpatient Intensive Nutrition Therapy Improves Survival and Frailty in Males With Alcohol-related ACLF - Randomized Controlled Trial.

Background & Aims: Improvement in the nutritional status of patients with acute-on-chronic liver failure (ACLF) may lead to reduction in morbidity and mortality. This study assessed the impact of dietician-supported outpatient intensive nutrition therapy (OINT) on survival and frailty in patients with alcohol-related ACLF METHODS: Seventy patients with alcohol-related ACLF (Asia Pacific Association for the Study of the Liver [APASL] criteria) and frailty were randomized 1:1 to receive standard medical therapy (SMT) plus OINT (intervention) vs SMT (control) alone. The primary outcome was an improvement in survival at 3 months. Secondary outcome measures included improvement in frailty, prognostic scores, and hospitalization.

Results: There was a significant improvement in overall survival in the OINT group as compared with the SMT group after 3 months of follow up (91.4% [standard error (SE), 4.7%] vs 57.1% [SE, 8.4%]; P < .00). On Cox regression model, inclusion in the intervention arm, baseline skeletal muscle index (SMI), and APASL ACLF Research Consortium (AARC score) were independent predictors of survival (P < .05). The liver frailty index (LFI) score also significantly improved in the OINT as compared with SMT (Δ-0.93; 95% confidence interval, -0.71 to 1.13 vs Δ -0.33; 95% confidence interval, -0.44 to 0.72; P < .00). The disease severity including MELD, MELD-Na, and AARC score showed a significant improvement in the OINT group as compared with the SMT group (P < .05). The patients in OINT group had lesser number of hospitalizations 6 (17%) vs 16 (45.7%) (P = .01) as compared with the SMT group.

Conclusion: Outpatient intensive nutrition therapy significantly improves survival, frailty, and disease severity with a reduction in number of hospitalizations and supports the key role of nutrition in treatment of patients with alcohol-related ACLF.

Clinical Trial Registry Number: ctri.nic.in/ CTRI/2022/01/039735.