High-protein delivery in mechanically ventilated patients: A study protocol for a randomized trial

Background: Critically ill patients are at risk of malnutrition; thus, optimal nutrition delivery is a key treatment for better outcomes. Inadequate energy and protein intake increase rate of hospital-acquired infection, duration of mechanical ventilation and mortality. However, there is no clear consensus regarding optimal protein dose in mechanically ventilated patients. In this study, we aim to compare between the effect of high and usual protein delivery on clinical outcomes in this patient group. Methods: This is a single-centered, open-labelled, parallel-group, randomized controlled study conducting in medical, surgical and trauma intensive care units (ICU) at a tertiary university hospital in Bangkok, Thailand. We plan to enroll 240 adult mechanically ventilated patients who are expected to require ventilator support for at least 3 days. The intervention group will be prescribed high protein dose (at least 1.5 g/kg/day) throughout ICU stay since day 4 until a maximum of 28 days, whereas the control group will be prescribed usual protein dose (1-1.3 g/kg/day). Nutrition is provided by enteral or parenteral route or both. The primary outcome is ventilator-free days at 28 days. The main secondary outcomes include the temporal change in muscle mass and SOFA score, rate of nosocomial infection and 28-day mortality. Conclusion: The robust evidence whether delivering high protein in critically ill patients improves outcome is lacking. This randomized trial will examine the consequence of high protein delivery in ICU population.