The Efficacy of High-Protein Nutritional Support on Mortality, Clinical Outcomes, and Nutritional Adequacy in Critically Ill Patients: A Double‑Center Randomized Controlled Trial Publisher



Badpeyma M ; Sedaghat A ; Moghaddam AB ; Khademrezaiyan M ; Sistanian F ; Bagherniya M ; Ranjbar G ; Fazeli F ; Norouzy A
Source: Nutrition and Metabolism Published:2025

Abstract

Background: Although nutritional support is crucial in intensive care, the impact of protein intake remains unclear, emphasizing the need for further randomized controlled trials. This study aimed to evaluate the effects of high-protein versus conventional-protein nutritional support on clinical outcomes in critically ill patients, with 60-day mortality as the primary endpoint. Method: In this double-blind, two-arm, parallel-group randomized controlled trial, 56 adult patients admitted to the intensive care unit [1] were enrolled. Participants received either high-protein support (2.2 g/kg/day, actual body weight [ABW]) or conventional-protein support (1.0 g/kg/day, ABW) for 12 days. Both groups targeted 25 kcal/kg/day energy intake. Patients and data analysts were blinded. Mortality was assessed at ICU discharge, on days 28 and 60, and at hospital discharge. Hospital mortality was defined as any death occurring during the hospital stay, including both the ICU and post-ICU periods. Mid-arm circumference (MAC) was measured as an indicator of muscle attenuation. Results: Mean protein intake was 1.67 ± 0.33 vs. 0.93 ± 0.10 g/kg/day in high- vs. conventional-protein groups (P < 0.05). In-hospital mortality was significantly lower in the high-protein group (8 patients [28.6%]) compared to the conventional-protein group (16 patients [57.1%]; adjusted P = 0.049). Although 60-day mortality was also lower in the high-protein group (28.6% vs. 53.6%), the difference did not reach statistical significance (adjusted P = 0.07). A significant reduction in MAC attenuation was observed in the high-protein group (P < 0.001). Conclusion: High-protein intake (1.67 g/kg/day) significantly reduced in-hospital mortality and improved preservation of muscle mass. Although 60-day mortality reduction was not significant, the trend suggests a meaningful benefit warranting further study. IRCT registration ID: IRCT20180619040151N4. © 2025 Elsevier B.V., All rights reserved.