Trial Review

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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
Scientific title
A multi-centre randomised controlled trial to evaluate whether early jejunal feeding increases energy delivery in critically ill patients
Secondary ID [1] 287809 0
nil known
Universal Trial Number (UTN)
Trial acronym
The ENTERIC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mechanically-ventilated, medical-surgical critically ill patients with reduced gastric motility 240 0
Condition category
Condition code
Other 271 271 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early jejunal feeding (using a frictional NJ tube).
Intervention code [1] 162 0
None
Comparator / control treatment
Standard feeding (commencing through an NG tube) throughout ICU stay.
Control group
Active

Outcomes
Primary outcome [1] 321 0
The amount of EN delivered during the ICU stay.
Timepoint [1] 321 0
during ICU stay
Secondary outcome [1] 714 0
Amount of EN delivered.
Timepoint [1] 714 0
During the first 10 days of the study.
Secondary outcome [2] 715 0
Cumulative proportion of EN delivered.
Timepoint [2] 715 0
Daily.
Secondary outcome [3] 716 0
Ventilator associated pneumonia rate.
Timepoint [3] 716 0
throughout ICU stay
Secondary outcome [4] 717 0
Duration of mechanical ventilation.
Timepoint [4] 717 0
End of mechanical ventilation
Secondary outcome [5] 718 0
Duration of hospitalisation.
Timepoint [5] 718 0
At discharge
Secondary outcome [6] 719 0
Mortality at hospital discharge.
Timepoint [6] 719 0
At discharge
Secondary outcome [7] 720 0
Success rate of placement into both the small bowel generally and the jejunum specifically.
Timepoint [7] 720 0
During study period
Secondary outcome [8] 721 0
Complication rates (as compared to the nasogastric tube).
Timepoint [8] 721 0
During study period

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).
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
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).

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)
Central randomisation using an interactive voice response system
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
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2006
Actual
30/01/2006
Date of last participant enrolment
Anticipated
Actual
30/04/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 327 0
Charities/Societies/Foundations
Name [1] 327 0
Australian and New Zealand Intensive Care Foundation
Country [1] 327 0
Australia
Primary sponsor type
Hospital
Name
ICU Rsearch Department, The Alfred Hospital, Melbourne Victoria
Address
Commercial road, melbourne 3004
Country
Australia
Secondary sponsor category [1] 258 0
None
Name [1] 258 0
No secondary sponsor
Address [1] 258 0
Country [1] 258 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1249 0
Alfred Hospital
Ethics committee address [1] 1249 0
Ethics committee country [1] 1249 0
Australia
Date submitted for ethics approval [1] 1249 0
Approval date [1] 1249 0
16/12/2006
Ethics approval number [1] 1249 0
Ethics committee name [2] 1250 0
Austin Hospital
Ethics committee address [2] 1250 0
Ethics committee country [2] 1250 0
Australia
Date submitted for ethics approval [2] 1250 0
Approval date [2] 1250 0
Ethics approval number [2] 1250 0
Ethics committee name [3] 1251 0
Bendigo Hospital
Ethics committee address [3] 1251 0
Ethics committee country [3] 1251 0
Australia
Date submitted for ethics approval [3] 1251 0
Approval date [3] 1251 0
Ethics approval number [3] 1251 0
Ethics committee name [4] 1252 0
Concord Hospital
Ethics committee address [4] 1252 0
Ethics committee country [4] 1252 0
Australia
Date submitted for ethics approval [4] 1252 0
Approval date [4] 1252 0
Ethics approval number [4] 1252 0
Ethics committee name [5] 1253 0
Frankston Hospital
Ethics committee address [5] 1253 0
Ethics committee country [5] 1253 0
Australia
Date submitted for ethics approval [5] 1253 0
Approval date [5] 1253 0
Ethics approval number [5] 1253 0
Ethics committee name [6] 1254 0
Geelong Hospital
Ethics committee address [6] 1254 0
Ethics committee country [6] 1254 0
Australia
Date submitted for ethics approval [6] 1254 0
Approval date [6] 1254 0
Ethics approval number [6] 1254 0
Ethics committee name [7] 1255 0
Gold Coast Hospital
Ethics committee address [7] 1255 0
Ethics committee country [7] 1255 0
Australia
Date submitted for ethics approval [7] 1255 0
Approval date [7] 1255 0
Ethics approval number [7] 1255 0
Ethics committee name [8] 1256 0
Monash Medical Centre
Ethics committee address [8] 1256 0
Ethics committee country [8] 1256 0
Australia
Date submitted for ethics approval [8] 1256 0
Approval date [8] 1256 0
Ethics approval number [8] 1256 0
Ethics committee name [9] 1257 0
Princess Alexandra Hospital
Ethics committee address [9] 1257 0
Ethics committee country [9] 1257 0
Australia
Date submitted for ethics approval [9] 1257 0
Approval date [9] 1257 0
Ethics approval number [9] 1257 0
Ethics committee name [10] 1258 0
Royal Darwin Hospital
Ethics committee address [10] 1258 0
Ethics committee country [10] 1258 0
Australia
Date submitted for ethics approval [10] 1258 0
Approval date [10] 1258 0
Ethics approval number [10] 1258 0
Ethics committee name [11] 1259 0
Royal North Shore Hospital
Ethics committee address [11] 1259 0
Ethics committee country [11] 1259 0
Australia
Date submitted for ethics approval [11] 1259 0
Approval date [11] 1259 0
Ethics approval number [11] 1259 0
Ethics committee name [12] 1260 0
St George Hospital
Ethics committee address [12] 1260 0
Ethics committee country [12] 1260 0
Australia
Date submitted for ethics approval [12] 1260 0
Approval date [12] 1260 0
Ethics approval number [12] 1260 0
Ethics committee name [13] 1261 0
St Vincents Hospital
Ethics committee address [13] 1261 0
Ethics committee country [13] 1261 0
Australia
Date submitted for ethics approval [13] 1261 0
Approval date [13] 1261 0
Ethics approval number [13] 1261 0
Ethics committee name [14] 1262 0
Western Hospital
Ethics committee address [14] 1262 0
Ethics committee country [14] 1262 0
Australia
Date submitted for ethics approval [14] 1262 0
Approval date [14] 1262 0
Ethics approval number [14] 1262 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35728 0
Dr Andrew Davies
Address 35728 0
c/o Frankston Hospital intensive care department
Country 35728 0
Australia
Phone 35728 0
+6130419770132
Fax 35728 0
Email 35728 0
andrew.davies@monash.edu
Contact person for public queries
Name 9351 0
Mrs Siouxzy Morrison
Address 9351 0
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
Country 9351 0
Australia
Phone 9351 0
+61 3 9903 0390
Fax 9351 0
+61 3 92762343
Email 9351 0
siouxzy.morrison@monash.edu
Contact person for scientific queries
Name 279 0
Dr. Andrew Davies
Address 279 0
Intensive Care Unit Research
National Trauma Research Institute
4th Floor Burnet Tower
PO Box 315
Prahran VIC 3181
Country 279 0
Australia
Phone 279 0
+61 3 92762607
Fax 279 0
+61 3 92763780
Email 279 0
a.davies@alfred.org.au

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.