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Trial registered on ANZCTR


Registration number
ACTRN12611000793910
Ethics application status
Approved
Date submitted
27/07/2011
Date registered
28/07/2011
Date last updated
3/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Augmented versus Routine approach to Giving Energy Trial (TARGET): A feasibility trial in the critically ill
Scientific title
The Augmented versus Routine approach to Giving Energy Trial (TARGET): A feasibility trial in the critically ill
Secondary ID [1] 262724 0
Nil
Universal Trial Number (UTN)
Trial acronym
TARGET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Energy requirement in the critically ill 270433 0
Condition category
Condition code
Diet and Nutrition 270579 270579 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1.5 kilocalorie per ml enteral feed formulation delivered via naso-gastric tube at a goal rate of 1ml per kilogram per hour (capped at 100ml/hr) continuously for a maximum of 10 days. Blinded enteral nutrition will cease prior to day 10 if one of the following occur: cessation of enteral nutrition by the treating clinicians, patient is discharged from the ICU, treating clinician decides that it is in the patients best interest to cease the study intervention or informed consent is withdrawn.
Intervention code [1] 267071 0
Treatment: Other
Comparator / control treatment
1.0 kilocalorie per ml enteral feed formulation delivered via naso-gastric tube at a goal rate of 1ml per kilogram per hour (capped at 100ml/hr) continuously for a maximum of 10 days. Blinded enteral nutrition will cease prior to day 10 if one of the following occur: cessation of enteral nutrition by the treating clinicians, patient is discharged from the ICU, treating clinician decides that it is in the patients best interest to cease the study intervention or informed consent is withdrawn.
Control group
Active

Outcomes
Primary outcome [1] 269321 0
To determine whether the administration of the treatment enteral feed (1.5 kcal/ml) increases mean daily energy delivery (kilocalorie per day) by > or equal to 20% compared to the control (1.0 kcal/ml). Energy delivery = calorie concentration of the feed X (volume delivered - gastric residual volume discarded)
Timepoint [1] 269321 0
Study enteral formula administered for up to 10 days. Mean daily energy delivered calculated over/ up to the 10 day treatment period.
Secondary outcome [1] 279372 0
Mortality
Timepoint [1] 279372 0
90 days
Hospital
Intensive Care Unit
Secondary outcome [2] 279373 0
Length of Stay recorded in time units (days) obtained from electronic admission databases and medical records
Timepoint [2] 279373 0
Hospital: admission to discharge in days
Intensive Care Unit: admission to discharge in days

Assessed at discharge
Secondary outcome [3] 279374 0
Invasive Mechanical Ventilator free days
Assessed at day 28: number of days patient off the invasive mechanical ventilator (equipment) collated. ICU observation flow charts used as source data to obtain information
Timepoint [3] 279374 0
28 days

Eligibility
Key inclusion criteria
Invasive mechanically ventilated critically ill patients
Expected intensive care unit stay > or = to 3 days
Suitable for, or receiving (within 12 hours) enteral nutrition.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Expected death within 24 hours
Patient not for active treatment
Target enteral feed volume contraindicated
Requirement for specific nutritional therapy other than study enteral formulation.

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)
Patients admitted to participating centre intensive care units will be screened for potential recruitment to the study. Eligible subjects enrolled by intensive care nursing, medical and dietician staff. Central randomisation via computer/ website. Following randomisation to either 1 kcal/ml or 1.5 kcal/ml pre -numbered blinded/ masked (with an enclosed opaque coloured plastic casing) enteral feed (boxed in groups of 6) will be allocated to subjects via the study website feed allocation web page. Nursing staff will locate the correct numbered enteral nutrition box from the store and assign to the study subject. Feed type concealed by covering the feed container and allocation concealment achieved/ maintained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised permuted block randomisation method with variable block sizes, stratified by centre in a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4320 0
5000
Recruitment postcode(s) [2] 4321 0
5011
Recruitment postcode(s) [3] 4322 0
2605
Recruitment postcode(s) [4] 4324 0
2050
Recruitment postcode(s) [5] 4325 0
3084

Funding & Sponsors
Funding source category [1] 267544 0
Hospital
Name [1] 267544 0
Royal Adelaide Hospital
Address [1] 267544 0
North Terrace
Adelaide
South Australia 5000
Country [1] 267544 0
Australia
Funding source category [2] 287908 0
Other Collaborative groups
Name [2] 287908 0
Australian and New Zealand College of Anaesthetists
Address [2] 287908 0
630 St Kilda Road

Melbourne Vic 3004

Country [2] 287908 0
Australia
Primary sponsor type
Individual
Name
Dr Marianne Chapman
Address
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 266581 0
Individual
Name [1] 266581 0
Dr Sandra Peake
Address [1] 266581 0
Department of Intensive Care
The Queen Elizabeth Hospital
1st Floor Main Building
28 Woodville Road,
Woodville
South Australia 5011
Country [1] 266581 0
Australia
Secondary sponsor category [2] 266582 0
Individual
Name [2] 266582 0
Dr Andrew Davies
Address [2] 266582 0
Intensive Care Unit
Alfred Hospital
Commercial Road
Melbourne
Victoria 3004
Country [2] 266582 0
Australia
Secondary sponsor category [3] 286635 0
Individual
Name [3] 286635 0
Stephanie O'Connor
Address [3] 286635 0
Intensive Care Unit Royal Adelaide Hospital North Terrace Adelaide South Australia 5000
Country [3] 286635 0
Australia
Secondary sponsor category [4] 286636 0
Individual
Name [4] 286636 0
Emma Ridley
Address [4] 286636 0
Department of Epidemiology & Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country [4] 286636 0
Australia
Secondary sponsor category [5] 286637 0
Individual
Name [5] 286637 0
Patricia Williams
Address [5] 286637 0
C/O The Queen Elizabeth Hospital
Intensive Care Unit
28 Woodville Rd
Woodville
South Australia 5011
Country [5] 286637 0
Australia
Secondary sponsor category [6] 287070 0
Individual
Name [6] 287070 0
Adam M Deane
Address [6] 287070 0
Intensive Care Unit
Critical Care Services
Royal Adelaide Hospital
North Terrace, Adelaide, SA 5000
Country [6] 287070 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269501 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 269501 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 269501 0
Australia
Date submitted for ethics approval [1] 269501 0
30/11/2010
Approval date [1] 269501 0
14/03/2011
Ethics approval number [1] 269501 0
101218

Summary
Brief summary
This trial is a feasibility/ pilot study to establish if the administration of the treatment enteral feed (1.5 kcal/ml) increases mean daily energy delivery (kilocalorie per day) by > or equal to 20% compared to the control (1.0 kcal/ml). The study will provide baseline data to allow for the planning and funding of a larger multi centre trial to determine if delivery of additional energy to critically ill adults over the first 10 days of their ICU stay affects clinically important outcomes.
Following the 10 day study treatment period, if required, patients in both groups will receive additional nutrition according to the centres standard care.
The pilot study will be conducted in 6 centres in Australia with 100 patients enrolled over a six month period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32942 0
A/Prof Marianne Chapman
Address 32942 0
Department of Acute Care Medicine
University of Adelaide
Royal Adelaide Hospital
North Terrace
Level 5, Eleanor Harrald Building
Adelaide
South Australia 5000
Country 32942 0
Australia
Phone 32942 0
+61 412 183 894
Fax 32942 0
Email 32942 0
marianne.chapman@health.sa.gov.au
Contact person for public queries
Name 16189 0
A/Prof Sandra Peake
Address 16189 0
Department of Intensive Care
The Queen Elizabeth Hospital
1st Floor Main Building
28 Woodville Road,
Woodville 5011
South Australia
Country 16189 0
Australia
Phone 16189 0
+61 8 8222 6000
Fax 16189 0
Email 16189 0
Sandra.Peake@health.sa.gov.au
Contact person for scientific queries
Name 7117 0
A/Prof Marianne Chapman
Address 7117 0
Director of Research/ Senior Staff Specialist
Intensive Care
Department of Critical Care Services
Royal Adelaide Hospital
North Terrace
Adelaide 5000
South Australia
Country 7117 0
Australia
Phone 7117 0
+61 8 8222 4000
Fax 7117 0
Email 7117 0
Marianne.Chapman@health.sa.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary