The Augmented Versus Routine Approach to Giving Energy Trial
TARGET
1 other identifier
interventional
4,000
2 countries
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2016
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedStudy Start
First participant enrolled
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedSeptember 13, 2018
September 1, 2018
2.1 years
November 11, 2014
September 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
Mortality status
Day 90
Secondary Outcomes (18)
Mortality
At hospital discharge an average of 28 days
Mortality
Day 28
Time from randomisation until death
Day 180
Number of days alive and not in ICU
Day 28
Number of days alive and not in hospital
Day 28
- +13 more secondary outcomes
Study Arms (2)
TARGET protocol EN 1.5 kcal/mL
EXPERIMENTALEnteral (EN) feed 1.5 kcal/mL. The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight.
TARGET protocol EN 1.0 kcal/mL
ACTIVE COMPARATOREnteral feed 1.0 kcal/mL The goal rate for administration of TARGET protocol EN is 1ml/kg/hr. To calculate the goal rate, weight is based on ideal body weight.
Interventions
Enteral feed 1.5 kcal/mL
Enteral feed 1.0 kcal/mL
Eligibility Criteria
You may qualify if:
- Intubated and receiving mechanical ventilation
- About to commence enteral nutrition or enteral nutrition commenced within the previous12 hours
- Expected to be receiving enteral nutrition in ICU until at least the day after tomorrow
You may not qualify if:
- Any Enteral Nutrition (EN) or Parenteral Nutrition (PN) received for \>12 hours in this ICU admission
- Treating clinician considers the EN goal rate (i.e.1ml/kg of ideal body weight per hour) to be clinically contraindicated e.g. requirement for fluid restriction
- Requirement for specific nutritional therapy as determined by the treating doctor or dietitian i.e. TARGET protocol EN not considered to be in the best interest of the patient
- Death is deemed to be imminent or inevitable during this admission and either the attending physician, patient or substitute decision maker is not committed to active treatment
- The patient has an underlying disease that makes survival to 90 days unlikely
- ≥ 15% burns
- Previously enrolled in this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
Gosford Hospital
Gosford, New South Wales, 2250, Australia
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010, Australia
Royal North Shore Hosptial
Sydney, New South Wales, 2065, Australia
Sydney Adventist Hospital
Sydney, New South Wales, 2076, Australia
Concord Hospital
Sydney, New South Wales, 2139, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Blacktown Hospital
Sydney, New South Wales, 2148, Australia
Liverpool Hospital
Sydney, New South Wales, 2170, Australia
St George Hospital
Sydney, New South Wales, 2217, Australia
Nepean Hospital
Sydney, New South Wales, 2747, Australia
Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Princess Alexandra Hospital
Brisbane, Queensland, 4102, Australia
Logan Hospital
Brisbane, Queensland, 4131, Australia
Toowoomba Hospital
Toowoomba, Queensland, 4350, Australia
Royal Adelaide Hosptial
Adelaide, South Australia, 5000, Australia
Queen Elizabeth Hospital
Adelaide, South Australia, 5011, Australia
Lyell McEwin
Adelaide, South Australia, 5112, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
Launceston General Hospital
Launceston, Tasmania, 7250, Australia
Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Footscray Hospital
Footscray, Victoria, 3011, Australia
Frankston Hosptial
Frankston, Victoria, 3199, Australia
University Hosptial Geelong
Geelong, Victoria, 3220, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Sunshine Hospital
Melbourne, Victoria, 3021, Australia
Royal Melbourne Hospital
Melbourne, Victoria, 3050, Australia
St Vincent's Hospital Melbourne
Melbourne, Victoria, 3065, Australia
Monash Health Dandenong Hospital
Melbourne, Victoria, 3175, Australia
Bunbury Hospital
Bunbury, Western Australia, 6230, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009, Australia
Fiona Stanley Hospital
Perth, Western Australia, 6150, Australia
St John of God Hospital Murdoch
Perth, Western Australia, 6150, Australia
North Shore Hospital
Auckland, 0622, New Zealand
Auckland City Hospital Cardiovascular Intensive Care Unit
Auckland, 1023, New Zealand
Auckland City Hospital Department of Critical Care Medicine
Auckland, 1023, New Zealand
Middlemore Hospital
Auckland, 2025, New Zealand
Christchurch Hospital
Christchurch, 4710, New Zealand
Waikato Hospital
Hamilton, 3204, New Zealand
Hawkes Bay Fallen Soldiers Memorial Hospital
Hastings, 4156, New Zealand
Hutt Valley Hospital
Lower Hutt, 5010, New Zealand
Nelson Hospital
Nelson, 7010, New Zealand
Rotorua Hospital
Rotorua, 3010, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Wellington Regional Hospital
Wellington, 6021, New Zealand
Related Publications (3)
Wittholz K, Fetterplace K, Chapple LA, Ridley EJ, Finnis M, Presneill J, Chapman M, Peake S, Bellomo R, Karahalios A, Deane AM. Six-month outcomes after traumatic brain injury in the Augmented versus Routine Approach to Giving Energy multicentre, double-blind, randomised controlled Trial (TARGET). Aust Crit Care. 2025 Mar;38(2):101116. doi: 10.1016/j.aucc.2024.09.001. Epub 2024 Oct 10.
PMID: 39389845DERIVEDArunachala Murthy T, Chapple LS, Lange K, Marathe CS, Horowitz M, Peake SL, Chapman MJ. Gastrointestinal dysfunction during enteral nutrition delivery in intensive care unit (ICU) patients: Risk factors, natural history, and clinical implications. A post-hoc analysis of The Augmented versus Routine approach to Giving Energy Trial (TARGET). Am J Clin Nutr. 2022 Aug 4;116(2):589-598. doi: 10.1093/ajcn/nqac113.
PMID: 35472097DERIVEDTARGET Investigators, for the ANZICS Clinical Trials Group; Chapman M, Peake SL, Bellomo R, Davies A, Deane A, Horowitz M, Hurford S, Lange K, Little L, Mackle D, O'Connor S, Presneill J, Ridley E, Williams P, Young P. Energy-Dense versus Routine Enteral Nutrition in the Critically Ill. N Engl J Med. 2018 Nov 8;379(19):1823-1834. doi: 10.1056/NEJMoa1811687. Epub 2018 Oct 22.
PMID: 30346225DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sandra Peake, MD
University of Adelaide
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2014
First Posted
December 3, 2014
Study Start
June 16, 2016
Primary Completion
July 10, 2018
Study Completion
August 1, 2018
Last Updated
September 13, 2018
Record last verified: 2018-09