Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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/NCT00256048




Registration number
NCT00256048
Ethics application status
Date submitted
17/11/2005
Date registered
21/11/2005
Date last updated
12/04/2017

Titles & IDs
Public title
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Scientific title
Efficacy of Nasojejunal Enteral Feeding in Critically Ill Patients.
Secondary ID [1] 0 0
2002.228
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
No intervention: Standard Care - Patients will receive enteral nutrition via a nasogastric tube as per standard feeding regime

Active comparator: Nasojejunal Arm - Patient will receive feeding via a nasojejunal feeding tube
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy of feeding
Timepoint [1] 0 0
participants will be followed until death, discharge from ICU, commencement of oral or parental nutrition or 28 days post ICU admission
Secondary outcome [1] 0 0
1. To determine the incidence of complications with enteral feeding via nasogastric and nasojejunal routes.
Timepoint [1] 0 0
participants will be followed until death, discharge from ICU, commencement of parental or oral nutrition or 28 days post ICU admission.
Secondary outcome [2] 0 0
2. To assess the efficacy of current strategies for optimising enteral feeding efficacy.
Timepoint [2] 0 0
participants will be followed until death, discharge from ICU commencement of oral or parental nutrition,or 28 days post ICU admission.

Eligibility
Key inclusion criteria
1. Adult patients (18years or over) admitted to the ICU with an expected stay of more than 48 hours.
2. Patients commenced on enteral feeding via a nasogastric tube 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
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. patients less than 18 years of age.
2. Patients with 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)
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2005
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Intensive Care Unit, Royal Melbourne Hospital, Grattan Street - Parkville
Recruitment postcode(s) [1] 0 0
3050 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine if naso-jejunal feeding (feeding beyond the stomach) improves the efficacy of enteral feeding (feeding into the gut) in critically ill patients.

The study hypothesis is that in patients who fail to establish enteral feeding via the nasogastric route, introduction of nasojejunal feeding will lead to more effective enteral feeding than the current regime involving staged introduction of promotility agents.
Trial website
https://clinicaltrials.gov/study/NCT00256048
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Megan Robertson
Address 0 0
Intensive Care Unit, Royal Melbourne Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00256048