Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00163813




Registration number
NCT00163813
Ethics application status
Date submitted
12/09/2005
Date registered
14/09/2005
Date last updated
26/02/2007

Titles & IDs
Public title
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care (ENTERIC) Study
Scientific title
The Early Nasojejunal Tube to Meet Energy Requirements in Intensive Care Study
Secondary ID [1] 0 0
232/04
Universal Trial Number (UTN)
Trial acronym
ENTERIC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Malabsorption Syndromes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The amount of EN delivered during the Intensive Care Unit (ICU) stay
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Amount of EN delivered during the first 10 days of the study
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Daily cumulative proportion of EN delivered
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Ventilator-associated pneumonia rate
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Duration of mechanical ventilation
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Duration of hospitalisation
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Mortality at hospital discharge
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Success rate of placement into both the small bowel, generally, and the jejunum, specifically
Timepoint [7] 0 0
Secondary outcome [8] 0 0
Complication rates (as compared to the nasogastric tube)
Timepoint [8] 0 0

Eligibility
Key inclusion criteria
ICU patients are eligible for enrolment if they meet all of the following:

* Age > 18 years old
* In ICU for < 48 hours prior to enrolment
* Receiving invasive mechanical ventilation (through an endotracheal tube or tracheostomy, but NOT a facemask) with an anticipated need for > 48 hours of mechanical ventilation
* Receiving a continuous infusion of any one of:

* morphine > 2 mg/hour,
* fentanyl > 20 mcg/hour, or
* pethidine > 20 mg/hour
* Either a single GRV > 150 mls (whilst receiving EN via a NG tube) or nasogastric drainage > 500 mls over 12 hours (whether receiving EN or not)
Minimum age
18 Years
Maximum age
No limit
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:

* Previous or recent surgery which has altered the anatomy of the upper 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 gastrostomy, 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 international normalized ratio [INR] > 4.0)

Study design
Purpose of the study
Prevention
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multi-centre randomised controlled trial comparing early jejunal feeding (using a frictional nasojejunal \[NJ\] tube) and standard feeding in critical illness.
Trial website
https://clinicaltrials.gov/study/NCT00163813
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Davies
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Andrew Davies
Address 0 0
Country 0 0
Phone 0 0
+61 3 92762607
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00163813