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Trial registered on ANZCTR
Registration number
ACTRN12605000149662
Ethics application status
Approved
Date submitted
10/08/2005
Date registered
15/08/2005
Date last updated
5/11/2015
Type of registration
Prospectively registered
Titles & IDs
Public title
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
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Scientific title
A multi-centre randomised controlled trial to evaluate whether early jejunal feeding increases energy delivery in critically ill patients
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Secondary ID [1]
287809
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nil known
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Universal Trial Number (UTN)
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Trial acronym
The ENTERIC Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mechanically-ventilated, medical-surgical critically ill patients with reduced gastric motility
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Condition category
Condition code
Other
271
271
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Early jejunal feeding (using a frictional NJ tube).
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Intervention code [1]
162
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None
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Comparator / control treatment
Standard feeding (commencing through an NG tube) throughout ICU stay.
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Control group
Active
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Outcomes
Primary outcome [1]
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The amount of EN delivered during the ICU stay.
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Assessment method [1]
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Timepoint [1]
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during ICU stay
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Secondary outcome [1]
714
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Amount of EN delivered.
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Assessment method [1]
714
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Timepoint [1]
714
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During the first 10 days of the study.
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Secondary outcome [2]
715
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Cumulative proportion of EN delivered.
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Assessment method [2]
715
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Timepoint [2]
715
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Daily.
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Secondary outcome [3]
716
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Ventilator associated pneumonia rate.
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Assessment method [3]
716
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Timepoint [3]
716
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throughout ICU stay
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Secondary outcome [4]
717
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Duration of mechanical ventilation.
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Assessment method [4]
717
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Timepoint [4]
717
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End of mechanical ventilation
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Secondary outcome [5]
718
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Duration of hospitalisation.
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Assessment method [5]
718
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Timepoint [5]
718
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At discharge
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Secondary outcome [6]
719
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Mortality at hospital discharge.
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Assessment method [6]
719
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Timepoint [6]
719
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At discharge
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Secondary outcome [7]
720
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Success rate of placement into both the small bowel generally and the jejunum specifically.
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Assessment method [7]
720
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Timepoint [7]
720
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During study period
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Secondary outcome [8]
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Complication rates (as compared to the nasogastric tube).
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Assessment method [8]
721
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Timepoint [8]
721
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During study period
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Eligibility
Key inclusion criteria
ICU patients are eligible for enrolment if they meet all of the following: in ICU for less than 48 hours prior to enrolment, receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, NOT a facemask) with an anticipated need for more than 48 hours of mechanical ventilation, receiving a continuous infusion of any one of morphine (>2mg/hour, fentanyl (> 20mcg/hour), or pethidine (>20mg/hour), either a single GRV > 150mls (whilst receiving EN via an NG tube, or nasogastic drainage >500mls over 12 hours (whether receiving EN or not).
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Minimum age
18
Years
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Maximum age
Not stated
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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
Patients will be ineligible for enrolment if they meet any of the following criteria: previous or recent surgery which has altered the anatomy of the gastrointestinal tract (eg. oesophagectomy, gastrectomy, any gastric anastomosis surgery, gastroplasty, pyloroplasty, pancreaticoduodenectomy (Whipple's procedure), known gastric malignancy, known oesophageal varices, current admission for peptic ulceration, current mechanical bowel obstruction, current gastostomy, jejunostomy, or surgically placed enteral tube in situ, contraindication to the use of the nose and mouth for enteral tube insertion (eg recent facial trauma or surgery), receiving nutritional support prior to ICU admission, severe coagulopathy (defined by platelet count <20 and/or INR>4.0).
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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)
Central randomisation using an interactive voice response system
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
COMPUTERISED RANDOMISATION WITH STRATIFICATION FOR ENROLLMENT SITE AND USE OF CATECHOLAMINESVariable Block Sizes
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
31/01/2006
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Actual
30/01/2006
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Date of last participant enrolment
Anticipated
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Actual
30/04/2009
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
180
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Accrual to date
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Final
181
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
327
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Charities/Societies/Foundations
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Name [1]
327
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Australian and New Zealand Intensive Care Foundation
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Address [1]
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melbourne, vic 3000
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Country [1]
327
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Australia
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Primary sponsor type
Hospital
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Name
ICU Rsearch Department, The Alfred Hospital, Melbourne Victoria
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Address
Commercial road, melbourne 3004
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Country
Australia
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Secondary sponsor category [1]
258
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None
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Name [1]
258
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No secondary sponsor
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Address [1]
258
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Country [1]
258
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
1249
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Alfred Hospital
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Ethics committee address [1]
1249
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Ethics committee country [1]
1249
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Australia
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Date submitted for ethics approval [1]
1249
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Approval date [1]
1249
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16/12/2006
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Ethics approval number [1]
1249
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Ethics committee name [2]
1250
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Austin Hospital
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Ethics committee address [2]
1250
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Ethics committee country [2]
1250
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Australia
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Date submitted for ethics approval [2]
1250
0
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Approval date [2]
1250
0
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Ethics approval number [2]
1250
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Ethics committee name [3]
1251
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Bendigo Hospital
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Ethics committee address [3]
1251
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Ethics committee country [3]
1251
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Australia
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Date submitted for ethics approval [3]
1251
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Approval date [3]
1251
0
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Ethics approval number [3]
1251
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Ethics committee name [4]
1252
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Concord Hospital
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Ethics committee address [4]
1252
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Ethics committee country [4]
1252
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Australia
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Date submitted for ethics approval [4]
1252
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Approval date [4]
1252
0
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Ethics approval number [4]
1252
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Ethics committee name [5]
1253
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Frankston Hospital
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Ethics committee address [5]
1253
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Ethics committee country [5]
1253
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Australia
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Date submitted for ethics approval [5]
1253
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Approval date [5]
1253
0
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Ethics approval number [5]
1253
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Ethics committee name [6]
1254
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Geelong Hospital
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Ethics committee address [6]
1254
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Ethics committee country [6]
1254
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Australia
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Date submitted for ethics approval [6]
1254
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Approval date [6]
1254
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Ethics approval number [6]
1254
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Ethics committee name [7]
1255
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Gold Coast Hospital
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Ethics committee address [7]
1255
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Ethics committee country [7]
1255
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Australia
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Date submitted for ethics approval [7]
1255
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Approval date [7]
1255
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Ethics approval number [7]
1255
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Ethics committee name [8]
1256
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Monash Medical Centre
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Ethics committee address [8]
1256
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Ethics committee country [8]
1256
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Australia
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Date submitted for ethics approval [8]
1256
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Approval date [8]
1256
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Ethics approval number [8]
1256
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Ethics committee name [9]
1257
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Princess Alexandra Hospital
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Ethics committee address [9]
1257
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Ethics committee country [9]
1257
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Australia
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Date submitted for ethics approval [9]
1257
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Approval date [9]
1257
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Ethics approval number [9]
1257
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Ethics committee name [10]
1258
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Royal Darwin Hospital
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Ethics committee address [10]
1258
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Ethics committee country [10]
1258
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Australia
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Date submitted for ethics approval [10]
1258
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Approval date [10]
1258
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Ethics approval number [10]
1258
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Ethics committee name [11]
1259
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Royal North Shore Hospital
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Ethics committee address [11]
1259
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Ethics committee country [11]
1259
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Australia
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Date submitted for ethics approval [11]
1259
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Approval date [11]
1259
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Ethics approval number [11]
1259
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Ethics committee name [12]
1260
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St George Hospital
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Ethics committee address [12]
1260
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Ethics committee country [12]
1260
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Australia
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Date submitted for ethics approval [12]
1260
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Approval date [12]
1260
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Ethics approval number [12]
1260
0
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Ethics committee name [13]
1261
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St Vincents Hospital
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Ethics committee address [13]
1261
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Ethics committee country [13]
1261
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Australia
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Date submitted for ethics approval [13]
1261
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Approval date [13]
1261
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Ethics approval number [13]
1261
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Ethics committee name [14]
1262
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Western Hospital
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Ethics committee address [14]
1262
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Ethics committee country [14]
1262
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Australia
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Date submitted for ethics approval [14]
1262
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Approval date [14]
1262
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Ethics approval number [14]
1262
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Summary
Brief summary
study completed and published Conclusions: In mechanically ventilated patients with mildly elevated gastric residual volumes and already receiving nasogastric nutrition, early nasojejunal nutrition did not increase energy delivery and did not appear to reduce the frequency of pneumonia. The rate of minor gastrointestinal hemorrhage was increased. Routine placement of a nasojejunal tube in such patients is not recommended.
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Trial website
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Trial related presentations / publications
Publication: Andrew R. Davies, Siouxzy S. Morrison, Michael J. Bailey, Rinaldo Bellomo, David J. Cooper, MD; Gordon S. Doig, PhD; Simon R. Finfer, FCICM; Daren K. Heyland, MD; for the ENTERIC Study Investigators and the ANZICS Clinical Trials Group. A multicenter, randomized controlled trial comparing early nasojejunal with nasogastric nutrition in critical illness. Crit Care Med 2012; 40: 2342–2348)
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Davies
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Address
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c/o Frankston Hospital intensive care department
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Country
35728
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Australia
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Phone
35728
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+6130419770132
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Fax
35728
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Email
35728
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[email protected]
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Contact person for public queries
Name
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Mrs Siouxzy Morrison
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Address
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ANZIC-RC – Australian & New Zealand Intensive Care Research Centre
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne VIC 3004
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Country
9351
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Australia
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Phone
9351
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+61 3 9903 0390
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Fax
9351
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+61 3 92762343
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Email
9351
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[email protected]
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Contact person for scientific queries
Name
279
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Dr. Andrew Davies
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Address
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Intensive Care Unit Research
National Trauma Research Institute
4th Floor Burnet Tower
PO Box 315
Prahran VIC 3181
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Country
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Australia
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Phone
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+61 3 92762607
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Fax
279
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+61 3 92763780
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Email
279
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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