CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,000 enrolled
Drug / intervention
TARGET protocol EN 1.5 kcal/mL +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02306746
NCT02306746Phase 3Completed
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The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial

Australian and New Zealand Intensive Care Research Centre·interventional·Posted Dec 3, 2014·Updated Sep 13, 2018

In Brief

A Phase 3 clinical trial evaluating TARGET protocol EN 1.5 kcal/mL and TARGET protocol EN 1.0 kcal/mL for Critical Illness. Completed, enrolled 4,000 participants across 46 sites in 2 countries.

Detailed Summary

Nutrition therapy is an essential standard of care for all critically ill patients who are mechanically ventilated and remain in the intensive care unit for more than a few days. The investigators plan to conduct a 4,000 patient, double-blind, randomised controlled trial to determine if augmentation of calorie delivery using energy dense enteral nutrition in mechanically ventilated patients improves 90 day survival when compared to routine care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCritical Illness
CountriesAustralia, New Zealand
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 3, 2014
Enrollment StartJun 16, 2016
Primary CompletionJul 10, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.6 years ago

Interventions

TARGET protocol EN 1.5 kcal/mLdietary

Enteral feed 1.5 kcal/mL

TARGET protocol EN 1.0 kcal/mLdietary

Enteral feed 1.0 kcal/mL