Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000570684
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
30/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised study to assess the efficacy of nasojejeunal verses nasogastric enteral feeding in critically ill patients during ICU stay.
Scientific title
Efficacy of nasojejeunal enteral feeding in critically ill patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients requiring enteral feeding 696 0
Condition category
Condition code
Other 772 772 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study examines the area of enteral feeding in critically ill patients. Current standard enteral feeding practice is via a naso-gastric tube with the addition of prokinetic agents for patients who fail to absorb their enteral nutrition. This study compares the efficacy of nasojejunal enteral feeding with naso-gastric enteral feeding with the addition of prokinetic agents. The duration of enteral feeding will be determined by the patient's nutritional requirements and their general condition. However, data will be collected for duration of enteral feeding, 28 days or ICU discharge, whichever occurs first.
Intervention code [1] 436 0
Treatment: Devices
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 982 0
The primary outcome of the study is to determine if nasojejunal feeding improves efficacy of enteral feeding in critically ill patients during ICU stay.
Timepoint [1] 982 0
Secondary outcome [1] 1856 0
To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Timepoint [1] 1856 0
Secondary outcome [2] 1857 0
To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Timepoint [2] 1857 0

Eligibility
Key inclusion criteria
1. Adult patients admitted to the ICU with an expected stay of more than 48h. 2. Patients commenced on enteral feeding via nasogastric route who fail to tolerate gastric feeding due to excessive gastric aspirate volumes. 3. Patients who consent or if the patient is incompetent, the next-of-kin who consent, to inclusion in the study.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients aged less than 18 years.2. Patients with a known allergy to promotility agents, metoclopramide or erythromycin.3. Patients with a contra-indication to nasojejunal feeding.

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)
Sequentially numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence was achieved through an computer generated matrix
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/09/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 853 0
Hospital
Name [1] 853 0
Royal Melbourne Hospital
Country [1] 853 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 720 0
None
Name [1] 720 0
Nil
Address [1] 720 0
Country [1] 720 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2118 0
The Royal Melbourne Hospital
Ethics committee address [1] 2118 0
Ethics committee country [1] 2118 0
Australia
Date submitted for ethics approval [1] 2118 0
Approval date [1] 2118 0
Ethics approval number [1] 2118 0

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

Contacts
Principal investigator
Name 35634 0
Address 35634 0
Country 35634 0
Phone 35634 0
Fax 35634 0
Email 35634 0
Contact person for public queries
Name 9625 0
Dr M Robertson
Address 9625 0
Intensive Care
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9625 0
Australia
Phone 9625 0
+61 3 93427441
Fax 9625 0
+61 3 93428812
Email 9625 0
[email protected]
Contact person for scientific queries
Name 553 0
Belinda Howe
Address 553 0
Intensive Care
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 553 0
Australia
Phone 553 0
+61 3 93427710
Fax 553 0
+61 3 93428812
Email 553 0
[email protected]

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.