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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02306746




Registration number
NCT02306746
Ethics application status
Date submitted
11/11/2014
Date registered
3/12/2014
Date last updated
13/09/2018

Titles & IDs
Public title
The Augmented Versus Routine Approach to Giving Energy Trial
Scientific title
The Augmented Versus Routine Approach to Giving Energy Trial: A Randomised Controlled Trial
Secondary ID [1] 0 0
ANZIC-RC/MC001
Universal Trial Number (UTN)
Trial acronym
TARGET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - TARGET protocol EN 1.5 kcal/mL
Other interventions - 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.


Other interventions: TARGET protocol EN 1.5 kcal/mL
Enteral feed 1.5 kcal/mL

Other interventions: TARGET protocol EN 1.0 kcal/mL
Enteral feed 1.0 kcal/mL
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
All cause mortality
Timepoint [1] 0 0
Day 90
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
At hospital discharge an average of 28 days
Secondary outcome [2] 0 0
Mortality
Timepoint [2] 0 0
Day 28
Secondary outcome [3] 0 0
Time from randomisation until death
Timepoint [3] 0 0
Day 180
Secondary outcome [4] 0 0
Number of days alive and not in ICU
Timepoint [4] 0 0
Day 28
Secondary outcome [5] 0 0
Number of days alive and not in hospital
Timepoint [5] 0 0
Day 28
Secondary outcome [6] 0 0
Ventilator free days
Timepoint [6] 0 0
Day 28
Secondary outcome [7] 0 0
Proportion of patients receiving vasopressor support
Timepoint [7] 0 0
Day 28
Secondary outcome [8] 0 0
Vasopressor free days
Timepoint [8] 0 0
Day 28
Secondary outcome [9] 0 0
Proportion of patients receiving any renal replacement therapy
Timepoint [9] 0 0
Day 28
Secondary outcome [10] 0 0
Renal replacement therapy free days
Timepoint [10] 0 0
Day 28
Secondary outcome [11] 0 0
Proportion of patients with positive blood cultures
Timepoint [11] 0 0
Day 28
Secondary outcome [12] 0 0
Proportion of patients requiring intravenous antimicrobials
Timepoint [12] 0 0
Day 28
Secondary outcome [13] 0 0
Mortality
Timepoint [13] 0 0
Day 180
Secondary outcome [14] 0 0
Quality of life assessment
Timepoint [14] 0 0
Day 180
Secondary outcome [15] 0 0
Functional outcomes for patients under 65 years in the work force
Timepoint [15] 0 0
Day 180
Secondary outcome [16] 0 0
Functional outcomes for patients under 65 years and not in the work force and patients 65 years and over living dependently
Timepoint [16] 0 0
Day 180
Secondary outcome [17] 0 0
Functional outcomes for patients 65 years and over living independently
Timepoint [17] 0 0
Day 180
Secondary outcome [18] 0 0
Cause-specific mortality
Timepoint [18] 0 0
Day 90

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2018
Sample size
Target
Accrual to date
Final
4000
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
St Vincent's Hospital Sydney - Sydney
Recruitment hospital [4] 0 0
Royal North Shore Hosptial - Sydney
Recruitment hospital [5] 0 0
Sydney Adventist Hospital - Sydney
Recruitment hospital [6] 0 0
Concord Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Sydney
Recruitment hospital [8] 0 0
Blacktown Hospital - Sydney
Recruitment hospital [9] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [10] 0 0
St George Hospital - Sydney
Recruitment hospital [11] 0 0
Nepean Hospital - Sydney
Recruitment hospital [12] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [13] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [14] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [15] 0 0
Logan Hospital - Brisbane
Recruitment hospital [16] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [17] 0 0
Royal Adelaide Hosptial - Adelaide
Recruitment hospital [18] 0 0
Queen Elizabeth Hospital - Adelaide
Recruitment hospital [19] 0 0
Lyell McEwin - Adelaide
Recruitment hospital [20] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [21] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [22] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [23] 0 0
Footscray Hospital - Footscray
Recruitment hospital [24] 0 0
Frankston Hosptial - Frankston
Recruitment hospital [25] 0 0
University Hosptial Geelong - Geelong
Recruitment hospital [26] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [27] 0 0
Sunshine Hospital - Melbourne
Recruitment hospital [28] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [29] 0 0
St Vincent's Hospital Melbourne - Melbourne
Recruitment hospital [30] 0 0
Monash Health Dandenong Hospital - Melbourne
Recruitment hospital [31] 0 0
Bunbury Hospital - Bunbury
Recruitment hospital [32] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment hospital [33] 0 0
Fiona Stanley Hospital - Perth
Recruitment hospital [34] 0 0
St John of God Hospital Murdoch - Perth
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2010 - Sydney
Recruitment postcode(s) [4] 0 0
2065 - Sydney
Recruitment postcode(s) [5] 0 0
2076 - Sydney
Recruitment postcode(s) [6] 0 0
2139 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Sydney
Recruitment postcode(s) [8] 0 0
2148 - Sydney
Recruitment postcode(s) [9] 0 0
2170 - Sydney
Recruitment postcode(s) [10] 0 0
2217 - Sydney
Recruitment postcode(s) [11] 0 0
2747 - Sydney
Recruitment postcode(s) [12] 0 0
- Sydney
Recruitment postcode(s) [13] 0 0
4029 - Brisbane
Recruitment postcode(s) [14] 0 0
4102 - Brisbane
Recruitment postcode(s) [15] 0 0
4131 - Brisbane
Recruitment postcode(s) [16] 0 0
4350 - Toowoomba
Recruitment postcode(s) [17] 0 0
5000 - Adelaide
Recruitment postcode(s) [18] 0 0
5011 - Adelaide
Recruitment postcode(s) [19] 0 0
5112 - Adelaide
Recruitment postcode(s) [20] 0 0
7000 - Hobart
Recruitment postcode(s) [21] 0 0
7250 - Launceston
Recruitment postcode(s) [22] 0 0
3550 - Bendigo
Recruitment postcode(s) [23] 0 0
3011 - Footscray
Recruitment postcode(s) [24] 0 0
3199 - Frankston
Recruitment postcode(s) [25] 0 0
3220 - Geelong
Recruitment postcode(s) [26] 0 0
3084 - Heidelberg
Recruitment postcode(s) [27] 0 0
3021 - Melbourne
Recruitment postcode(s) [28] 0 0
3050 - Melbourne
Recruitment postcode(s) [29] 0 0
3065 - Melbourne
Recruitment postcode(s) [30] 0 0
3175 - Melbourne
Recruitment postcode(s) [31] 0 0
6230 - Bunbury
Recruitment postcode(s) [32] 0 0
6009 - Perth
Recruitment postcode(s) [33] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hastings
Country [5] 0 0
New Zealand
State/province [5] 0 0
Lower Hutt
Country [6] 0 0
New Zealand
State/province [6] 0 0
Nelson
Country [7] 0 0
New Zealand
State/province [7] 0 0
Rotorua
Country [8] 0 0
New Zealand
State/province [8] 0 0
Tauranga
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02306746
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sandra Peake, MD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries