Study protocol for the Augmented versus Routine Approach to Giving Energy Trial (TARGET).

BACKGROUND: Nutrition is routinely provided to critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. Nasogastric feeding, which is standard practice for patients who are unable to tolerate oral nutrition, typically delivers less than 60% of the recommended energy requirements. It remains uncertain whether the delivery of about 100% of the recommended energy goals via the enteral route will affect survival and other important clinical outcomes.

OBJECTIVE: To describe the protocol for a large-scale, multicentre, double-blind, randomised, controlled, parallelgroup, phase 3 clinical trial to determine if augmentation of calorie delivery using an energy-dense enteral nutrition formulation in mechanically ventilated patients increases 90-day survival when compared with routine care.

METHODS: 4000 patients who are mechanically ventilated and are expected to receive enteral nutrition for more than 2 days are to be randomised to an energy-dense formulation (1.5 kcal/mL) or routine enteral feed formulation (1 kcal/mL), given at the same rate. The primary outcome is 90-day all-cause mortality. Secondary outcomes include cause-related mortality up to Day 90; all-cause mortality at hospital discharge and at Days 28 and 180 after randomisation; and ventilator-, vasopressorand renal replacement-free days to Day 28. Health-related quality of life and functional assessments will be conducted at Day 180 after randomisation.

RESULTS AND CONCLUSIONS: The results of this trial are expected to determine whether increased energy delivery, using an energy-dense formula can improve clinically meaningful outcomes, including survival.