Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001314516
Ethics application status
Approved
Date submitted
11/11/2015
Date registered
1/12/2015
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Early and late effects of 24 hours supplemental parenteral amino acids on whole-body protein turnover in critically ill patients.
Scientific title
Early and late effects of 24 hours supplemental parenteral amino acids on whole-body protein turnover in critically ill patients.
Secondary ID [1] 287843 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critical illness 296729 0
Condition category
Condition code
Diet and Nutrition 296967 296967 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 296968 296968 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Critical patients treated in a medical/surgical ICU or intermediary unit will receive supplemental parenteral amino acids in addition to their ongoing nutrition. The supplemental amino acids will be given as an equivalent of 1 gram protein/kg body weight per day for 24 hours. A mixture of amino acids (Glavamin, Fresenius) will be infused at a continuous rate of 0.083 g/kg/h for 24 hours. Infusion rates for the supplement will be automatically registered in the on-line clinical management system (ClinSoft). Measurements of whole-body protein kinetics is performed just before supplementation and at 3 and 24 hours after start of the supplementation.

Intervention code [1] 293236 0
Treatment: Other
Comparator / control treatment
Patients are their own controls, with a measurement just before the intervention.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296585 0
Whole-body protein balance.

Whole-body protein balance is calculated by the difference between whole-body protein synthesis and breakdown rates which are assessed by the infusion of stable isotope labelled phenylalanine and tyrosine, detection of its amounts in plasma of the patients by mass spectrometry and kinetic modelling.
Timepoint [1] 296585 0
Whole-body protein balance measured just before (baseline) and at 3 and 24 hours after start of the intervention.
Secondary outcome [1] 318806 0
Whole-body phenylalanine oxidation.

Whole-body phenylalanine is calculated from the decarboxylation rate which is assessed by the infusion of stable isotope labelled phenylalanine and tyrosine, detection of its amounts in plasma of the patients by mass spectrometry and kinetic modelling.
Timepoint [1] 318806 0
Whole-body phenylalanine oxidation will be measured just before (baseline) and at 3 and 24 hours after start of the intervention.
Secondary outcome [2] 318807 0
Plasma amino acid profile.

Plasma amino acid profile is measured by established HPLC technique on plasma samples from the patients.
Timepoint [2] 318807 0
Plasma amino acid profile is measured just before (baseline) and at 3 and 24 after start of the infusion.

Eligibility
Key inclusion criteria
Critically ill patients with expected stable nutrition for 30 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Ongoing dialysis

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Previous results using the same kind of patients, same intervention and same methodology showed that 10 patients are sufficient to detect a change from a negative protein balance to a a zero protein balance with a 80% statistical power (Liebau et al. Crit Care 2015, 19:106.)

For analyses of the outcome measured ANOVA for repeated samples or Friedman test will be used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2015
Actual
12/01/2016
Date of last participant enrolment
Anticipated
31/10/2016
Actual
12/05/2016
Date of last data collection
Anticipated
Actual
12/07/2016
Sample size
Target
10
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 7323 0
Sweden
State/province [1] 7323 0

Funding & Sponsors
Funding source category [1] 292366 0
Government body
Name [1] 292366 0
Stockholm County Council
Country [1] 292366 0
Sweden
Primary sponsor type
Individual
Name
Olav Rooyackers
Address
Department of Anesthesiology and Intensive Care,
Clintec, Karolinska Institutet,
Karolinska University Hospital,
14186 Huddinge
Country
Sweden
Secondary sponsor category [1] 291052 0
None
Name [1] 291052 0
Address [1] 291052 0
Country [1] 291052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293836 0
Regionala etikprovningsnamnden i Stockholm
Ethics committee address [1] 293836 0
Box 289 (Nobels vag 12 A)
171 77 Stockholm
Ethics committee country [1] 293836 0
Sweden
Date submitted for ethics approval [1] 293836 0
Approval date [1] 293836 0
21/01/2015
Ethics approval number [1] 293836 0
2011/2029 and 2015/0048

Summary
Brief summary
Critical ill patients loose lean body and muscle mass at a high rate. This fast wasting is related to a worsened clinical outcome. Appropriate protein feeding might prevent or reduce the wasting and thereby affect outcome. However, the best amount of protein for this is not well characterized. In a previous study we have shown that an 3 hour parenteral supplementation of amino acid to these patients results in a positive protein balance and that the extra amino acids are not oxidizes (Liebau et al. Crit Care 2015, 19:106.). The aim of the present study is to investigate if this effect persists over a longer time and therefore measurements of protein balance and oxidation are performed during 24 hours of supplementation after both 3 and 24 hours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61446 0
Prof Olav Rooyackers
Address 61446 0
Department of Anesthesiology and Intensive Care,
Clintec, Karolinska Institutet,
Karolinska University Hospital,
14186 Huddinge
Country 61446 0
Sweden
Phone 61446 0
+46 8 58586182
Fax 61446 0
Email 61446 0
olav.rooyackers@ki.se
Contact person for public queries
Name 61447 0
Prof Olav Rooyackers
Address 61447 0
Department of Anesthesiology and Intensive Care,
Clintec, Karolinska Institutet,
Karolinska University Hospital,
14186 Huddinge
Country 61447 0
Sweden
Phone 61447 0
+46 8 58586182
Fax 61447 0
Email 61447 0
olav.rooyackers@ki.se
Contact person for scientific queries
Name 61448 0
Prof Olav Rooyackers
Address 61448 0
Department of Anesthesiology and Intensive Care,
Clintec, Karolinska Institutet,
Karolinska University Hospital,
14186 Huddinge
Country 61448 0
Sweden
Phone 61448 0
+46 8 58586182
Fax 61448 0
Email 61448 0
olav.rooyackers@ki.se

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
EmbaseA supplemental intravenous amino acid infusion sustains a positive protein balance for 24 hours in critically ill patients.2017https://dx.doi.org/10.1186/s13054-017-1892-x
N.B. These documents automatically identified may not have been verified by the study sponsor.