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.