ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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Go to the Login page, click ‘reset password’ and follow the instructions.
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Create a new password that meets requirements.
Return to the Login page and enter your new password. A verification code will be sent to your email.
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Learn more about MFA and its importance on the Australian Signals Directorate website.

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 registered on ANZCTR

Registration number

ACTRN12606000367549

Ethics application status

Not yet submitted

Date submitted

16/08/2006

Date registered

22/08/2006

Date last updated

22/08/2006

Type of registration

Prospectively registered

Titles & IDs

Public title

A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients.

Scientific title

A randomised controlled comparison of early post-pyloric versus early gastric feeding to meet nutritional targets in ventilated intensive care patients.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Enteral feeding of ventilated critically ill patients

Condition category

Condition code

Oral and Gastrointestinal

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Once entered into the study, patients will be randomised to either enteral feeding via the stomach using a nasogastric tube, or post pyloric via a smaller, Corflo tube.

The tube will be inserted using a standard technique

Patients in the post-pyloric group will also receive a gastric tube to allow for aspiration of stomach contents

If a post-pyloric tube cannot be inserted, a gastric tube will be placed and the patient fed according to our standard protocol

Once placed, feeds will be initiated immediately. The current ICU feeding protocol will be used to escalate feeds to target

The nutritional requirements for each patient will be calculated using a standard formula

Patients will remain in the study until they are able to eat or are discharged from ICU

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group

Active

Outcomes

Primary outcome [1]

TIme from initiation of feeds to time at which goal feeds are reached.

Timepoint [1]

Primary outcome [2]

Total calorie intake during intensive care admission.

Timepoint [2]

Secondary outcome [1]

Complications associated with small bowel feeding.

Timepoint [1]

Secondary outcome [2]

Number of days in Intensive care.

Timepoint [2]

Secondary outcome [3]

Number of days requiring mechanical ventilation days.

Timepoint [3]

Eligibility

Key inclusion criteria

All critically ill patients admitted to intensive care expected to require at least 24 hours of mechanical ventilation.

Minimum age

18 Years

Maximum age

Not stated

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Ischaemic bowel, bowel obstruction, severe exacerbation of inflammatory bowel disease, acute variceal bleeding and patients deemed high risk for anastamotic leaks by the surgeons.

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)

Sealed opaque numbered envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer generated simple randomization

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Subjects are blinded

Phase

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

15/09/2006

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Primary sponsor type

Individual

Name

Hayden White

Address

Country

Secondary sponsor category [1]

Individual

Name [1]

Kellie Sosnowski

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Summary

Brief summary

Early enteral feeding is recognised as an important contributor to patient outcome in critically ill patients. This goal can be hard to achieve as patient often have difficulty tolerating nasogastric feeds. This is due to the tendency for seriously ill patients to develop a gastric ileus. One option is to begin intravenous feeding. However, parentral feeding is expensive and associated with a number of complications including sepsis. 
The insertion of post-pyloric tubes has been advocated for a number of years to overcome the problems with gastric feeding. Unfortunately, these tubes are difficult to place blindly, often requiring the assistance of gastroenterologists or radiologists. This often leads to delays instituting feeds, negating the benefits of early feeding. A number of centres have described protocols for placing small bowel tubes but with limited success. 
Recently, a simple technique with a relatively high success rate was described by a group of researchers. Our ICU has adopted their protocol and over the past few months have noted a success rate of nearly 100%. The implications are that by using this method, we are able to entrally feed virtually all our patients from day one. 
The aim of our study is to compare gastric and post-pyloric feeding in ventilated, critically ill patients. Our primary end-points include: time to insertion of feeding tube, time to reaching goal feeds and total nutrition received over ICU stay as proportion of calculated ideal. As part of the analysis we intend to compare complication rates between groups.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Hayden White

Address

Intensive Care Unit Logan Hospital Cnr Armstrong & Loganlea Roads MEADOWBROOK QLD 4133

Country

Australia

Phone

32998899

Fax

[email protected]

Contact person for scientific queries

Name

Hayden White

Address

Intensive Care Unit Logan Hospital Cnr Armstrong & Loganlea Roads MEADOWBROOK Qld 4133

Country

Australia

Phone

32998899

Fax

[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.

Trial Review

Documents added manually

Documents added automatically