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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02306746
Registration number
NCT02306746
Ethics application status
Date submitted
11/11/2014
Date registered
3/12/2014
Titles & IDs
Public title
The Augmented Versus Routine Approach to Giving Energy Trial
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Scientific title
The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial
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Secondary ID [1]
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ANZIC-RC/MC001
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Universal Trial Number (UTN)
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Trial acronym
TARGET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - TARGET protocol EN 1.5 kcal/mL
Treatment: Other - TARGET protocol EN 1.0 kcal/mL
Experimental: TARGET protocol EN 1.5 kcal/mL - Enteral (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.
Active comparator: TARGET protocol EN 1.0 kcal/mL - Enteral 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.
Treatment: Other: TARGET protocol EN 1.5 kcal/mL
Enteral feed 1.5 kcal/mL
Treatment: Other: TARGET protocol EN 1.0 kcal/mL
Enteral feed 1.0 kcal/mL
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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All cause mortality
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Assessment method [1]
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Mortality status
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Timepoint [1]
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Day 90
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Secondary outcome [1]
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Mortality
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Assessment method [1]
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Mortality status
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Timepoint [1]
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At hospital discharge an average of 28 days
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Secondary outcome [2]
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Mortality
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Assessment method [2]
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Mortality status
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Timepoint [2]
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Day 28
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Secondary outcome [3]
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Time from randomisation until death
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Assessment method [3]
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Mortality status
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Timepoint [3]
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Day 180
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Secondary outcome [4]
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Number of days alive and not in ICU
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Assessment method [4]
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Mortality status
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Timepoint [4]
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Day 28
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Secondary outcome [5]
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Number of days alive and not in hospital
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Assessment method [5]
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Mortality status
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Timepoint [5]
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Day 28
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Secondary outcome [6]
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Ventilator free days
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Assessment method [6]
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Organ support status
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Timepoint [6]
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Day 28
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Secondary outcome [7]
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Proportion of patients receiving vasopressor support
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Assessment method [7]
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Organ support proportion
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Timepoint [7]
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Day 28
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Secondary outcome [8]
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Vasopressor free days
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Assessment method [8]
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Organ support status
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Timepoint [8]
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Day 28
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Secondary outcome [9]
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Proportion of patients receiving any renal replacement therapy
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Assessment method [9]
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Organ support proportion
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Timepoint [9]
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Day 28
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Secondary outcome [10]
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Renal replacement therapy free days
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Assessment method [10]
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Organ support status
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Timepoint [10]
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Day 28
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Secondary outcome [11]
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Proportion of patients with positive blood cultures
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Assessment method [11]
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Blood stream infection proportion
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Timepoint [11]
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Day 28
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Secondary outcome [12]
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Proportion of patients requiring intravenous antimicrobials
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Assessment method [12]
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Patients requiring intravenous antimicrobials
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Timepoint [12]
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Day 28
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Secondary outcome [13]
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Mortality
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Assessment method [13]
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Mortality status
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Timepoint [13]
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Day 180
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Secondary outcome [14]
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Quality of life assessment
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Assessment method [14]
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European Quality of Life 5 Dimensions
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Timepoint [14]
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Day 180
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Secondary outcome [15]
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Functional outcomes for patients under 65 years in the work force
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Assessment method [15]
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Questions from the Australian Labour Force Survey
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Timepoint [15]
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Day 180
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Secondary outcome [16]
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Functional outcomes for patients under 65 years and not in the work force and patients 65 years and over living dependently
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Assessment method [16]
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World Health Organization Disability Assessment Schedule 2.0
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Timepoint [16]
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Day 180
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Secondary outcome [17]
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Functional outcomes for patients 65 years and over living independently
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Assessment method [17]
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Adelaide Activities Profile
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Timepoint [17]
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Day 180
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Secondary outcome [18]
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Cause-specific mortality
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Assessment method [18]
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Mortality status
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Timepoint [18]
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Day 90
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/06/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2018
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Sample size
Target
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Accrual to date
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Final
4000
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Gosford Hospital - Gosford
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Recruitment hospital [3]
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St Vincent's Hospital Sydney - Sydney
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Recruitment hospital [4]
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Royal North Shore Hosptial - Sydney
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Recruitment hospital [5]
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Sydney Adventist Hospital - Sydney
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Recruitment hospital [6]
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Concord Hospital - Sydney
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Recruitment hospital [7]
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Westmead Hospital - Sydney
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Recruitment hospital [8]
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Blacktown Hospital - Sydney
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Recruitment hospital [9]
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Liverpool Hospital - Sydney
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Recruitment hospital [10]
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St George Hospital - Sydney
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Recruitment hospital [11]
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Nepean Hospital - Sydney
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Recruitment hospital [12]
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Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [13]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [14]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [15]
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Logan Hospital - Brisbane
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Recruitment hospital [16]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [17]
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Royal Adelaide Hosptial - Adelaide
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Recruitment hospital [18]
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Queen Elizabeth Hospital - Adelaide
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Recruitment hospital [19]
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Lyell McEwin - Adelaide
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Recruitment hospital [20]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [21]
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Launceston General Hospital - Launceston
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Recruitment hospital [22]
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Bendigo Hospital - Bendigo
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Recruitment hospital [23]
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Footscray Hospital - Footscray
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Recruitment hospital [24]
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Frankston Hosptial - Frankston
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Recruitment hospital [25]
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University Hosptial Geelong - Geelong
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Recruitment hospital [26]
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Austin Hospital - Heidelberg
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Recruitment hospital [27]
0
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Sunshine Hospital - Melbourne
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Recruitment hospital [28]
0
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Royal Melbourne Hospital - Melbourne
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Recruitment hospital [29]
0
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment hospital [30]
0
0
Monash Health Dandenong Hospital - Melbourne
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Recruitment hospital [31]
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Bunbury Hospital - Bunbury
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Recruitment hospital [32]
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Sir Charles Gairdner Hospital - Perth
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Recruitment hospital [33]
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Fiona Stanley Hospital - Perth
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Recruitment hospital [34]
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St John of God Hospital Murdoch - Perth
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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2250 - Gosford
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Recruitment postcode(s) [3]
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2010 - Sydney
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Recruitment postcode(s) [4]
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2065 - Sydney
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Recruitment postcode(s) [5]
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2076 - Sydney
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Recruitment postcode(s) [6]
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2139 - Sydney
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Recruitment postcode(s) [7]
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2145 - Sydney
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Recruitment postcode(s) [8]
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2148 - Sydney
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Recruitment postcode(s) [9]
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2170 - Sydney
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Recruitment postcode(s) [10]
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2217 - Sydney
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Recruitment postcode(s) [11]
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2747 - Sydney
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Recruitment postcode(s) [12]
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- Sydney
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Recruitment postcode(s) [13]
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4029 - Brisbane
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Recruitment postcode(s) [14]
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4102 - Brisbane
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Recruitment postcode(s) [15]
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4131 - Brisbane
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Recruitment postcode(s) [16]
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4350 - Toowoomba
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Recruitment postcode(s) [17]
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5000 - Adelaide
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Recruitment postcode(s) [18]
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5011 - Adelaide
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Recruitment postcode(s) [19]
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5112 - Adelaide
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Recruitment postcode(s) [20]
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7000 - Hobart
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Recruitment postcode(s) [21]
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7250 - Launceston
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Recruitment postcode(s) [22]
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3550 - Bendigo
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Recruitment postcode(s) [23]
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3011 - Footscray
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Recruitment postcode(s) [24]
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3199 - Frankston
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Recruitment postcode(s) [25]
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3220 - Geelong
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Recruitment postcode(s) [26]
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3084 - Heidelberg
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Recruitment postcode(s) [27]
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3021 - Melbourne
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Recruitment postcode(s) [28]
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3050 - Melbourne
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Recruitment postcode(s) [29]
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3065 - Melbourne
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Recruitment postcode(s) [30]
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3175 - Melbourne
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Recruitment postcode(s) [31]
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6230 - Bunbury
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Recruitment postcode(s) [32]
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6009 - Perth
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Recruitment postcode(s) [33]
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6150 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Hamilton
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Country [4]
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New Zealand
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State/province [4]
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Hastings
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Country [5]
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New Zealand
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State/province [5]
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Lower Hutt
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Country [6]
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New Zealand
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State/province [6]
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Nelson
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Country [7]
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New Zealand
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State/province [7]
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Rotorua
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Country [8]
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New Zealand
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State/province [8]
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Tauranga
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Country [9]
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New Zealand
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State/province [9]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02306746
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Trial related presentations / publications
Arunachala 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. TARGET 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.
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Public notes
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Contacts
Principal investigator
Name
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Sandra Peake, MD
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Address
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University of Adelaide
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Country
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Phone
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Fax
0
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02306746