Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000571673
Ethics application status
Approved
Date submitted
10/09/2005
Date registered
30/09/2005
Date last updated
6/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
THE EFFECTS OF NUTRITIONAL SUPPORT OF CRITICALLY ILL PATIENTS REQUIRING MECHANICAL VENTILATION AS ASSESSED BY V/Q RATIO
Scientific title
THE EFFECTS OF NUTRITIONAL SUPPORT OF CRITICALLY ILL PATIENTS REQUIRING MECHANICAL VENTILATION
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients who require mechanical ventilation 697 0
Condition category
Condition code
Other 773 773 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients who agree to participate in the study and fulfil the inclusion criteria will be randomised to one of two treatment groups.
1.Standard therapy group will receive high-carbohydrate low-fat enteral feed (16.7% protein, 30% fat and 53.3% carbohydrates) at a target rate as decided by the treating physician and dietician for a maximum of 5 days following randomisation.
2.Alternative therapy group will receive high-fat low-carbohydrate enteral feed (16.7% protein, 55.2% fat and 28.1% carbohydrates) at a target rate as decided by the treating physician and dietician for a maximum of 5 days following randomisation.
All patients will receive enteral feeding by continuous flow for 24hrs/day.
The decision to commence or cease enteral feeding will remain with the treating physician.
The measurement of VO2, VCO2, resting energy expenditure and respiratory quotient will be made on all participants 12 hourly for a maximum of 5 days using the indirect calorimeter. The indirect calorimeter is connected to the expiratory outlet of the ventilator, collecting and analyzing gas that is normally discharged into the atmosphere.
Intervention code [1] 452 0
None
Comparator / control treatment
Standard therapy group will receive high-carbohydrate low-fat enteral feed (16.7% protein, 30% fat and 53.3% carbohydrates) at a target rate as decided by the treating physician and dietician for a maximum of 5 days following randomisation.
Control group
Active

Outcomes
Primary outcome [1] 983 0
The primary aim of this study is to determine if high-fat low-carbohydrate enteral feed reduces the carbon dioxide production in patients with respiratory failure.
Timepoint [1] 983 0
12 hourly for a maximum of 5 days .
Primary outcome [2] 984 0
The primary aim of this study is to determine if high-fat low-carbohydrate enteral feed reduces respiratory quotient in patients with respiratory failure.
Timepoint [2] 984 0
12 hourly for a maximum of 5 days .
Secondary outcome [1] 1858 0
1. if high-fat low-carbohydrate enteral feed reduces the number of days spent on mechanical ventilation or the ICU length of stay.
Timepoint [1] 1858 0
Secondary outcome [2] 1859 0
2.To assess whether an excessive carbohydrate load increases CO2 production (VCO2) in patients with acute respiratory failure.
Timepoint [2] 1859 0

Eligibility
Key inclusion criteria
1.Adult patients admitted with acute respiratory failure (PaO2/FiO2 < 300), needing mechanical ventilation and who are expected to require mechanical ventilation for more than 48 hours.2.Patients who are to receive enteral feeding via a gastric or post-pyloric feeding tube.3.Patients or next-of-kin who consent to participate 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 under the age of 18 years.2.Patients with a contra-indication to enteral feeding.3.Patients receiving total parenteral nutrition.4.Patients who are not receiving active medical management or who are expected to die within 24 hours at the time of study entry.5.Patients with diabetes mellitus, renal failure or liver failure. 6.Patients who are already enrolled in another study that may influence the outcome of this study.7.Patients or next-of-kin who do not consent to participate in the study.

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 envelpoes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation 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
Recruiting
Date of first participant enrolment
Anticipated
4/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 854 0
Hospital
Name [1] 854 0
Intensive Care Research department Funding, Royal Melbourne Hospital
Country [1] 854 0
Australia
Primary sponsor type
Hospital
Name
Intensive Care Unit, RMH
Address
Country
Australia
Secondary sponsor category [1] 721 0
None
Name [1] 721 0
Nil
Address [1] 721 0
Country [1] 721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2119 0
Royal Melbourne Hospital
Ethics committee address [1] 2119 0
Ethics committee country [1] 2119 0
Australia
Date submitted for ethics approval [1] 2119 0
Approval date [1] 2119 0
Ethics approval number [1] 2119 0

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

Contacts
Principal investigator
Name 35584 0
Address 35584 0
Country 35584 0
Phone 35584 0
Fax 35584 0
Email 35584 0
Contact person for public queries
Name 9641 0
Dr M Robertson
Address 9641 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 9641 0
Australia
Phone 9641 0
+61 3 93427441
Fax 9641 0
+61 3 93428812
Email 9641 0
megan.robertson@mh.org.au
Contact person for scientific queries
Name 569 0
Belinda Howe
Address 569 0
Intensive Care Unit
Royal Melbourne Hospital
Grattan Street
Parkville VIC 3050
Country 569 0
Australia
Phone 569 0
+61 3 93427710
Fax 569 0
+61 3 93428812
Email 569 0
belinda.howe@mh.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.