Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001285640
Ethics application status
Approved
Date submitted
3/12/2014
Date registered
9/12/2014
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Energy Requirements of Critically Ill Obese Patients: Does Goal Directed Nutrition Using Indirect Calorimetry Improve Energy Delivery?
Scientific title
Energy Requirements of Critically Ill Obese Patients: Does Goal Directed Nutrition Using Indirect Calorimetry Improve Energy Delivery?
Secondary ID [1] 284129 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 291207 0
Obesity 291208 0
Condition category
Condition code
Diet and Nutrition 291560 291560 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is 'Goal Directed Nutrition Therapy' involving the use of indirect calorimetry (IC) to assess energy expenditure, and then targeting the provision of energy from enteral or parenteral nutrition to match this.
To use IC to measure a ventilated patients energy expenditure, the indirect calorimeter is connected to their ventilator circuit to measure the gas exchange and calculate expended energy.
Participants in the intervention group will have IC within 24 hours of enrollment and then twice weekly until 14 days or extubation. The test will be carried out by a dietitian. The duration of each test will vary depending on the patient, however the usual duration is 5-20 minutes.
Intervention code [1] 288829 0
Treatment: Other
Comparator / control treatment
Active control (standard care) where energy requirements are estimated using the Schofield equation.
Control group
Active

Outcomes
Primary outcome [1] 291616 0
The primary outcome of this study is daily delivered energy as a proportion of measured energy expenditure (using indirect calorimetry) to determine adequacy of energy provision, and compare groups with respect to under and over feeding.
Timepoint [1] 291616 0
Daily energy intake over 14 days
Secondary outcome [1] 307163 0
Energy expenditure (using indirect calorimetry) at four timepoints:within 24 hours enrolment & twice weekly until day 14 (or until extubation)
Timepoint [1] 307163 0
14 days (or until extubation)
Secondary outcome [2] 311828 0
Daily protein intake assessed as grams of protein received divided by weight in kilograms.
Timepoint [2] 311828 0
14 days (or until extubation)
Secondary outcome [3] 311829 0
Duration of mechanical ventilation (number of days from intubation to extubation).
Timepoint [3] 311829 0
Until extubation (censored at 60 days)
Secondary outcome [4] 311830 0
Length of ICU admission
Timepoint [4] 311830 0
Until ICU discharge (censored at 60 days)
Secondary outcome [5] 311831 0
Length of hospital admission
Timepoint [5] 311831 0
Until hospital discharge (censored at 60 days)
Secondary outcome [6] 311832 0
Survival
Timepoint [6] 311832 0
60 days
Secondary outcome [7] 311833 0
Hand grip strength (measured using a hand grip strength dynamometer)
Timepoint [7] 311833 0
ICU and hospital discharge (censored at 60 days)
Secondary outcome [8] 311834 0
Highest level of function scale (using ICU mobility scale)
Timepoint [8] 311834 0
ICU and hospital discharge (censored at 60 days)
Secondary outcome [9] 311835 0
Quality of life questionnaire (EQ-5D)
Timepoint [9] 311835 0
At hospital discharge (censored at 60 days)

Eligibility
Key inclusion criteria
- BMI greater than or equal to 30m2/Kg
- Within 72 hours of ICU admission at the time of enrolment
- Mechanically ventilated at the time of enrolment and expected to remain ventilated until the day after tomorrow
- At least 18 years of age
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- There is a long term technical contraindication to a IC measurement
- Are not expected to commence nutrition therapy in next 24hrs for any reason
- Death is imminent or deemed highly likely in the next 96 hours.
- There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying illness
- Are known to be pregnant
- The treating clinician does not believe the study to be in the best interest of the patient
- Patient is not expected to continue with nutrition therapy for > 72 hours

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)
Patients will be screened for eligibility in The Alfred ICU. Those meeting the inclusion criteria and exempt of the exclusion criteria should be considered for enrolment. Patients will be screened daily on weekdays using patient lists and ward round by the project manager.
Patients will be unable to provide prospective informed consent, as they will be sedated and receiving mechanical ventilation. Informed consent will be obtained from the most appropriate Person Responsible, in accordance with section 4.4.10 of the NHMRC National Statement. Delayed consent for continued participation and long-term follow up will be sought from the participant when they have suitably recovered capacity.
Eligible patients will be enrolled by study personnel and then randomised using a manual randomisation technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. 40 opaque envelopes contained "goal directed nutrition" and 40 contained "standard care", these were shuffled and then when a patient in enrolled the front envelope was taken to allocate the patient. 10 envelopes from each arm were labelled before recruitment commenced to identify those who will also be enrolled in the sub-study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The proposed sample size is based on data from previous nutrition studies conducted in Australia and New Zealand. Assuming a mean daily energy delivery of 1300+/-400 kcal/day in the control (usual treatment) group and expecting at least a 20% increase in targeted energy group, using a 2-groups t-test at 5% significance and 80% power, the estimated minimum required sample size is: n=38 per group (i.e. 76 in total).

Data analysis will be carried out using the Statistical package for the social sciences, version 20 (SPSS Inc, Chicago, IL). Data will be assessed for normality using the Kolmogorov-Smirnov test. Data will be expressed as means or medians and standard deviations (SDs) or standard error of the mean (SEM).
Appropriate statistical tests (parametric and non parametric tests) will be carried out to determine differences between and within groups. Where significance is observed, appropriate post-hoc tests will be employed. Statistical significance will be determined as p<0.05.
A biostatistician will be consulted to ensure correct statistical procedures are employed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2014
Actual
Date of last participant enrolment
Anticipated
30/11/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2176 0
The Alfred - Prahran
Recruitment postcode(s) [1] 7856 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 288837 0
Charities/Societies/Foundations
Name [1] 288837 0
ANZ Trustees
Country [1] 288837 0
Australia
Primary sponsor type
Individual
Name
A/Prof Ibolya Nyulasi
Address
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country
Australia
Secondary sponsor category [1] 287531 0
Individual
Name [1] 287531 0
Emma Ridley
Address [1] 287531 0
Department of Epidemiology & Preventive Medicine
Monash University
The Alfred Centre
99 Commercial Road
Melbourne Vic 3004
Country [1] 287531 0
Australia
Secondary sponsor category [2] 288497 0
Individual
Name [2] 288497 0
Dr Audrey Tierney
Address [2] 288497 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country [2] 288497 0
Australia
Secondary sponsor category [3] 288498 0
Individual
Name [3] 288498 0
Emily Dynon
Address [3] 288498 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country [3] 288498 0
Australia
Secondary sponsor category [4] 288499 0
Individual
Name [4] 288499 0
Dr Andrew Udy
Address [4] 288499 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country [4] 288499 0
Australia
Secondary sponsor category [5] 288500 0
Individual
Name [5] 288500 0
Professor Carlos Scheinkestel
Address [5] 288500 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Country [5] 288500 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290677 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 290677 0
The Alfred
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181 Australia
Ethics committee country [1] 290677 0
Australia
Date submitted for ethics approval [1] 290677 0
28/04/2014
Approval date [1] 290677 0
12/06/2014
Ethics approval number [1] 290677 0
191/14

Summary
Brief summary
In this study of 80 obese (BMI greater than or equal to 30Kg/m2) ICU patients we will estimate requirements and deliver nutrition as per current standard practice in 40 patients; the remaining 40 patients will have their energy requirements measured using indirect calorimetry and the provision of nutrition therapy will be targeted to meet this value. We will measure important outcomes to enable us to determine whether this goal directed approach allows nutrition therapy to better meet the patients requirements, and also whether this difference impacts on the patient’s recovery.
We hypothesize that patients who receive Goal Directed Nutrition Therapy will receive a higher proportion of their energy needs (energy delivered divided by measured energy expenditure) and that this may lead to improved clinical and functional outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46382 0
A/Prof Ibolya Nyulasi
Address 46382 0
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181
Country 46382 0
Australia
Phone 46382 0
+613 9076 3063
Fax 46382 0
Email 46382 0
[email protected]
Contact person for public queries
Name 46383 0
A/Prof Ibolya Nyulasi
Address 46383 0
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181
Country 46383 0
Australia
Phone 46383 0
+613 9076 3063
Fax 46383 0
Email 46383 0
[email protected]
Contact person for scientific queries
Name 46384 0
A/Prof Ibolya Nyulasi
Address 46384 0
Alfred Health
55 Commercial Road
Melbourne VIC 3004
PO Box 315 Prahran
VIC 3181
Country 46384 0
Australia
Phone 46384 0
+613 9076 3063
Fax 46384 0
Email 46384 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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