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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00256074




Registration number
NCT00256074
Ethics application status
Date submitted
17/11/2005
Date registered
21/11/2005
Date last updated
12/04/2017

Titles & IDs
Public title
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Scientific title
The Effects of Nutritional Support of Critically Ill Patients Requiring Mechanical Ventilation
Secondary ID [1] 0 0
2003.263
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
Treatment: Surgery - Enteral feeding formula

Other: Standard Therapy Group - Standard therapy group. Will receive high carbohydrate, low fat enteral feeding, (16.7% protein, 30% fat and 53.3% carbohydrate). The target rate is determined by the treating physician and dietician, for a minimum of 5 days following randomisation.

Other: Alternative Therapy Group - 2.Alternative therapy group will receive high-fat, low carbohydrate enteral feeding, (16.7% protein, 55.2% fat and 28.1% carbohydrates. At a target rate determined by the treating physician and dietician, for a maximum of 5 days following randomisation.


Treatment: Surgery: Enteral feeding formula
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine if high-fat low-carbohydrate enteral feeding reduces the carbon dioxide production and the respiratory quotient in patients with respiratory failure.
Timepoint [1] 0 0
patients will be followed until death or hospital discharge
Secondary outcome [1] 0 0
1. If high-fat, low-carbohydrate enteral feeding reduces carbon dioxide production, dead space ventilation the number of days spent on mechanical ventilation,or the length of ICU stay, hospital length of stay or mortality.
Timepoint [1] 0 0
patients will be followed until death or hospital discharge

Eligibility
Key inclusion criteria
1. Adult patient, 18 years or older admitted with acute respiratory failure (PaO2/FiO2
<300), needing mechanical ventilation. Are expected to be 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 their next-of-kin consent to participate 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 under the age of 18 years

2. Patients with contra-indications to enteral feeding

3. Patients receiving total parental nutrition

4. Patients who are already enrolled in another study that may influence the outcome of
this study.

5. Patients who are not receiving active medical management or are expected to die within
24 hours at the time of study entry.

6. Patients with diabetes mellitus, renal failure or liver failure.

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)
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
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2007
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Intensive Care Unit, The Royal Melbourne Hospital, - 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 assess the impact of different feeding solutions on patients
with breathing difficulty being supported by a breathing machine.

The aim of the study is to determine if high fat-low carbohydrate feeding reduces the carbon
dioxide production in patients with respiratory failure.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00256074
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Megan Robertson, MBBS
Address 0 0
Melbourne Health
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/ct2/show/NCT00256074