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https://hdl.handle.net/2440/132285
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Type: | Journal article |
Title: | Study protocol for the augmented versus routine approach to giving energy trial (TARGET) |
Author: | Williams, P. |
Citation: | Critical Care and Resuscitation, 2018; 20(1):6-14 |
Publisher: | Informit |
Issue Date: | 2018 |
ISSN: | 1441-2772 2652-9335 |
Statement of Responsibility: | Patricia Williams, The TARGET Investigators on behalf of the Australian and New Zealand Intensive Care Society Clinical Trials Group |
Abstract: | 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, parallel-group, 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-, vasopressor and 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. |
Keywords: | TARGET Investigators on behalf of the Australian and New Zealand Intensive Care Society Clinical Trials Group |
Description: | Patricia Williams is Corresponding Author |
Rights: | © College of Intensive Care Medicine, 2018 |
DOI: | 10.3316/informit.438817864137331 |
Grant ID: | http://purl.org/au-research/grants/nhmrc/1078026 |
Appears in Collections: | Medicine publications |
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