Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000366257
Ethics application status
Approved
Date submitted
17/04/2009
Date registered
27/05/2009
Date last updated
16/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of parenteral protein intake in intensive care patients
Scientific title
Nutritional status and outcomes in critically ill patients receiving a standard or a high-protein parenteral nutrition triple-phase solution
Secondary ID [1] 283709 0
nil
Universal Trial Number (UTN)
Trial acronym
EPPII
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critical illness 4625 0
Condition category
Condition code
Diet and Nutrition 4925 4925 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients requiring intravenous (parenteral) nutrition in the intensive care unit will be randomised to receive one of two triple phase parenteral nutrition solutions for the duration of their need for parenteral nutrition while in the intensive care unit. The protein in the parenteral nutrition solution is in the form of a balanced set of amino acids. The higher-protein intervention solution has 53g of amino acids per 1000kcal.
Intervention code [1] 4384 0
Treatment: Other
Comparator / control treatment
Patients requiring intravenous (parenteral) nutrition in the intensive care unit will be randomised to receive one of two triple phase parenteral nutrition solutions for the duration of their need for parenteral nutrition while in the intensive care unit. The protein in the parenteral nutrition solution is in the form of a balanced set of amino acids. The lower-protein control solution is similar to the standard product currently used in the intensive care unit, with 39g of amino acids per 1000kcal.
Control group
Active

Outcomes
Primary outcome [1] 5772 0
nitrogen balance measured using a 24-hour urine collection to calculate 24-hour urinary urea nitrogen excretion and compare with nitrogen intake from the parenteral nutrition solution.
Timepoint [1] 5772 0
after 5 days on parenteral nutrition
Secondary outcome [1] 241732 0
handgrip dynamometer measurement
Timepoint [1] 241732 0
on discharge from the intensive care unit

Eligibility
Key inclusion criteria
adult intensive care patients requiring parenteral nutrition - our intensive care unit is an adult unit by Department of Health criteria, that is it accepts patients from 16 years upwards and all patients in the unit will be eligible for the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients under 16 years of age

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)
consecutive patients requiring parenteral nutrition will be enrolled and randomised to standard or high-protein parenteral nutrition with retrospective consent. Parenteral nutrition solutions will be concealed by sealed identical light-protective covers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/06/2009
Actual
25/11/2013
Date of last participant enrolment
Anticipated
Actual
30/11/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3928 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 9842 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 4806 0
Self funded/Unfunded
Name [1] 4806 0
Country [1] 4806 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4339 0
University
Name [1] 4339 0
University of Sydney
Address [1] 4339 0
City Road,
University of Sydney
UNIVERSITY OF SYDNEY
NSW 2006
Country [1] 4339 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6853 0
Sydney South West Area Health Service Ethics Review Committee (Royal Prince Alfred Hospital zone)
Ethics committee address [1] 6853 0
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 6853 0
Australia
Date submitted for ethics approval [1] 6853 0
20/04/2009
Approval date [1] 6853 0
16/11/2009
Ethics approval number [1] 6853 0
X09-0228 & HREC/09/RPAH/373

Summary
Brief summary
There is no good evidence to support any particular level of protein input in critical illness. Some studies have indicated a level above which there is no additional benefit to short-term indicators (such as nitrogen balance), but none of the studies have looked at the effects on concrete outcomes such as time in the intensive care unit, or functional measures after discharge. The aim of this study is to look at such concrete measures after administering two different levels of protein to patients who are fed intravenously. The hypothesis is that a higher level of protein will improve outcomes.
Trial website
Trial related presentations / publications
no publications as yet
Public notes

Contacts
Principal investigator
Name 29506 0
Ms Suzie Ferrie
Address 29506 0
Department of Nutrition & Dietetics
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country 29506 0
Australia
Phone 29506 0
+ 61 2 9515 8053
Fax 29506 0
Email 29506 0
[email protected]
Contact person for public queries
Name 12753 0
Ms Suzie Ferrie
Address 12753 0
Department of Nutrition & Dietetics
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country 12753 0
Australia
Phone 12753 0
+61 2 95158053
Fax 12753 0
Email 12753 0
[email protected]
Contact person for scientific queries
Name 3681 0
Ms Suzie Ferrie
Address 3681 0
Department of Nutrition & Dietetics
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Country 3681 0
Australia
Phone 3681 0
+61 2 95158053
Fax 3681 0
Email 3681 0
[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.