Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000333617
Ethics application status
Approved
Date submitted
19/03/2014
Date registered
27/03/2014
Date last updated
28/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Metabolic handling of dietary protein in critically ill patients
Scientific title
Effect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients
Secondary ID [1] 284289 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 291433 0
Condition category
Condition code
Diet and Nutrition 291804 291804 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 291807 291807 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enteral feeding is initiated in critically ill patients. Due to tolerance problems that are common in these patients, a low dose of enteral nutrition is given initially. At an infusion rate of 20 ml/h, nutrient supply is 0.73 g/h casein and 2.73 g/h maltodextrin. Study nutrition contains casein intrinsically labeled with L-[1-13C]-phenylalanine (van Loon, L.J., et al., J Dairy Sci, 2009. 92:4812-22). This allows measurement of the dietary contribution to whole-body protein kinetics. Measurements of whole-body protein kinetics are made before and after six hours of enteral feeding.
Intervention code [1] 289011 0
Treatment: Other
Comparator / control treatment
Parameters of whole-body protein turnover are measured before and after initiation of enteral protein feeding. Patients function as their own controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291723 0
Parameters of steady-state whole body protein kinetics are calculated from arterial plasma enrichments of isotope labeled phenylalanine and tyrosine tracers. Tracers are given intravenously and as intrinsically labelled casein via nasogastric tube. Calculations yield values for whole-body protein breakdown and synthesis. The arithmetic difference of breakdown and synthesis is the net protein balance which is the main outcome. The intermediary results are also reported for clarity.
Timepoint [1] 291723 0
Before and 6 hrs post post initiation of enteral protein feeding
Secondary outcome [1] 307355 0
Splanchnic extraction fraction of phenylalanine from dietary casein is calculated from arterial plasma enrichments of isotope labeled phenylalanine and tyrosine tracers. Tracers are given intravenously and as intrinsically labelled casein via nasogastric tube.
Timepoint [1] 307355 0
6 hrs post initiation of enteral protein feeding
Secondary outcome [2] 307357 0
Plasma amino acid profile
Timepoint [2] 307357 0
Before and 6 hrs post initiation of enteral protein feeding

Eligibility
Key inclusion criteria
ICU patients who are tracheally intubated or tracheostomized; clinical indication for inititating enteral feeding
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior enteral feeding; milk protein allergy; ongoing renal replacement therapy or other extracorporeal blood treatment; liver failure; ongoing hemorrhage requiring transfusion; major surgery during the study period; contraindications to enteral feeding via nasogastric tube

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are recruited from ICU clientele as available
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
Single group
Other design features
The study nutrition has not previously been used in the protocol described or a similar protocol. Therefore, healthy volunteers are studied in a pilot phase to establish feasibility of the protocol. This is not a separate study; rather, this part of the study is included in the ethical committee's approval and in the publication.
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Values for the primary outcome are compared within-group, before vs. after intervention, appropriately by Wilcoxon matched pairs test.

For physiological reasons, the secondary outcome "splanchnic extraction fraction of phenylalanine from dietary casein" can only be studied after intervention and results are therefore presented decriptively.

Comparison of results for patients vs. subjects from the reference (pilot) group is not intended, because the great differences in physiology preclude a meaningful interpretation.

A sample size calculation is not made, because the effect size is unknown and cannot be estimated from available knowledge. There are no experimental results in comparable patient groups that would allow such a estimation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/12/2010
Date of last participant enrolment
Anticipated
Actual
12/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 5906 0
Sweden
State/province [1] 5906 0

Funding & Sponsors
Funding source category [1] 288919 0
Government body
Name [1] 288919 0
Regional Agreement on Medical Training and Clinical Research (ALF) between Stockholm County Council and Karolinska Institutet
Country [1] 288919 0
Sweden
Funding source category [2] 288920 0
Charities/Societies/Foundations
Name [2] 288920 0
European Society of Intensive Care Medicine
Country [2] 288920 0
Belgium
Primary sponsor type
Individual
Name
Prof Olav Rooyackers
Address
Karolinska Institutet
Inst. for klinisk vetenskap, intervention och teknik
Enheten for anestesi
Karolinska Universitetssjukhuset, Huddinge, K32
141 86 Stockholm
Country
Sweden
Secondary sponsor category [1] 287613 0
None
Name [1] 287613 0
Address [1] 287613 0
Country [1] 287613 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290747 0
Regionala etikprovningsnamnden i Stockholm
Ethics committee address [1] 290747 0
Box 289 (Nobels vag 12 A)
171 77 Stockholm
Ethics committee country [1] 290747 0
Sweden
Date submitted for ethics approval [1] 290747 0
Approval date [1] 290747 0
03/12/2009
Ethics approval number [1] 290747 0
2009/1647-31/3

Summary
Brief summary
Critically ill patients suffer from catabolism, i.e. protein loss, which may contribute to complications such as muscle weakness, protracted ventilator treatment, and delayed recovery. Appropriate feeding may alleviate catabolism, but ideal feeding strategies are controversial, partly because the underlying physiology is poorly understood.

We investigate the effect of protein feeding via nasogastric feeding tube in critically ill patients. Using stable isotope techniques, we measure whether whole-body protein catabolism is improved after initiation of feeding.
Trial website
Trial related presentations / publications
Felix Liebau, Jan Wernerman, Luc JC van Loon, and Olav Rooyackers

Effect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients. Am J Clin Nutr. 2015 Mar;101(3):549-57.

doi: 10.3945/ajcn.114.091934.
Public notes

Contacts
Principal investigator
Name 47054 0
Prof Olav Rooyackers
Address 47054 0
Karolinska Institutet
Inst. for klinisk vetenskap, intervention och teknik
Enheten for anestesi
Karolinska Universitetssjukhuset, Huddinge, K32
141 86 Stockholm
Country 47054 0
Sweden
Phone 47054 0
+46-8-58580553
Fax 47054 0
Email 47054 0
[email protected]
Contact person for public queries
Name 47055 0
Felix Liebau
Address 47055 0
Inst. for klinisk vetenskap, intervention och teknik
Enheten for anestesi
Karolinska Universitetssjukhuset, Huddinge, K32
141 86 Stockholm
Country 47055 0
Sweden
Phone 47055 0
+46-8-58580553
Fax 47055 0
Email 47055 0
[email protected]
Contact person for scientific queries
Name 47056 0
Felix Liebau
Address 47056 0
Inst. for klinisk vetenskap, intervention och teknik
Enheten for anestesi
Karolinska Universitetssjukhuset, Huddinge, K32
141 86 Stockholm
Country 47056 0
Sweden
Phone 47056 0
+46-8-58580553
Fax 47056 0
Email 47056 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
SourceTitleYear of PublicationDOI
EmbaseEffect of initiating enteral protein feeding on whole-body protein turnover in critically ill patients.2015https://dx.doi.org/10.3945/ajcn.114.091934
N.B. These documents automatically identified may not have been verified by the study sponsor.