PEP uP (Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol) in Surgical Patients—A Multicenter Pilot Randomized Controlled Trial

Abstract

Background: The Enhanced Protein-Energy Provision via the Enteral Route Feeding Protocol (PEP uP) has been shown to be feasible, safe, and effective in delivering significantly more energy/protein, though it has not been well studied in surgical/trauma patients. We hypothesized that PEP uP will effectively increase energy/protein delivery to critically ill surgical/trauma patients. Methods: This multicenter, prospective, randomized pilot study included adult patients admitted to surgical service who were expected to require mechanical ventilation for >24 hours and intensive care unit (ICU) care for >72 hours. Subjects were randomized to PEP uP or standard care. The PEP uP protocol includes initiation at goal rate, semi-elemental formula, prophylactic prokinetic agents, 24-hour volume-based goals, and modular protein supplementation. The primary outcome was nutrition adequacy over the first 12 ICU days. Results: Thirty-six subjects were enrolled. Slow recruitment resulted in early trial termination by the sponsor. There were no baseline differences between groups. PEP uP patients received more protein (106.8 ± 37.0 vs 78.5 ± 30.3 g/d, P = 0.02). Energy delivery was not significantly different (1400.0 ± 409.5 vs 1237.9 ± 459.1 kcal, P = 0.25). Vomiting was more common in the PEP uP patients (32% vs 12%, P = 0.03). PEP uP protocol violations included 2 patients (15.4%) not receiving pro-motility medications, 3 (23.1%) not receiving volume-based feeds as ordered, and 4 (30.8%) not receiving supplemental protein. Conclusions: In surgical/trauma patients, PEPuP seemed to improve protein delivery but was difficult to implement successfully and may increase vomiting rates.