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Trial registered on ANZCTR


Registration number
ACTRN12613001298707
Ethics application status
Approved
Date submitted
19/11/2013
Date registered
22/11/2013
Date last updated
22/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Plasma glutamine is associated with multiple organ failure in critically ill children
Scientific title
Plasma glutamine is associated with multiple organ failure in critically ill children
Secondary ID [1] 283615 0
Nil secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness 290540 0
Condition category
Condition code
Metabolic and Endocrine 290938 290938 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this observational study, consecutive critically ill children (n = 149) admitted to the PICU of a tertiary university hospital as well as a reference group of healthy children (n=60) were included. Plasma glutamine concentration and the pediatric logistic organ dysfunction score (PELOD) were determined at admission and at day 5 for patients still in the PICU.
Intervention code [1] 288307 0
Not applicable
Comparator / control treatment
Not applicable - Observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290920 0
To evaluate if low plasma glutamine concentration is associated with the development of multiple organ failure, using the pediatric logistic organ dysfunction score (PELOD) as a multiple organ failure score and as a surrogate marker of mortality.
Timepoint [1] 290920 0
At admission.
Secondary outcome [1] 305600 0
To longitudinally investigate the development of plasma glutamine levels in critically ill patients and relate this to changes in organ failure, using the pediatric logistic organ dysfunction score (PELOD) as a multiple organ failure score and as a surrogate marker of mortality..
Timepoint [1] 305600 0
For this, the patients still in the ICU at day 5 were sampled again.

Eligibility
Key inclusion criteria
An expected PICU-stay > 24 hours, informed consent and sampling within 48 hours after admittance.
Minimum age
No limit
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Absence of informed consent at 48 hours after admittance, failure of sampling or age > 18 years.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Normality was assessed using the Kolmogorov-Smirnov test. Data normally distributed are given as means and S.D. Nonparametric data values are given as median (IQR). Student´s t-test, Wilson matched pair test, ANOVA followed by Tukey post-hoc test, Fisher`s exact test and Pearson´s linear regression analysis were used when applicable. (Statistica Statsoft, Tulsa, Okla, USA).
Estimation of patients needed to achieve the objectives of the study: plasma glutamine concentration as a marker of morbidity in PICU patients has not been investigated before. The variability is not known. However, in a study investigating adult ICU patients (n=80) a reduction by 50 % in mortality has been shown if the concentration of plasma glutamine is > 430 micromol/L. In the present study, one objective is to longitudinally investigate patients who stay > 5 days in the PICU. In Scandinavian PICU:s it is known that approximately 30 % of the patients will have a PICU-stay > 5 days. Therefore, the aim is to include 150 patients which will result in approximately 45 patients staying > 5 days in the PICU which would be sufficient to discover a difference in mortalty.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5641 0
Sweden
State/province [1] 5641 0

Funding & Sponsors
Funding source category [1] 288295 0
Government body
Name [1] 288295 0
The Swedish Medical Research Council (projects 04210 and 14244)
Address [1] 288295 0
Vastra jarnvagsgatan 3
10138 Stockholm
Country [1] 288295 0
Sweden
Funding source category [2] 288296 0
University
Name [2] 288296 0
The Country Council of Stockholm (projects 502033 and 511126).
Address [2] 288296 0
FoUU-enheten
Karolinska Universitetssjukhuset
17176 Stockholm
Country [2] 288296 0
Sweden
Primary sponsor type
University
Name
Stockholms lans landstng. The Country Council of Stockholm (projects 502033 and 511126).
Address
FoUU-enheten
Karolinska Universitetssjukhuset
17176 Stockholm
Country
Sweden
Secondary sponsor category [1] 287016 0
Government body
Name [1] 287016 0
The Swedish Medical Research Council (projects 04210 and 14244) Vetenskapsradet.
Address [1] 287016 0
Vastra stationsgatan 3
10138 Stockholm
Country [1] 287016 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290192 0
The Regional Ethical Review Board in Stockholm.
Ethics committee address [1] 290192 0
Nobels vag 9, plan d3
171 65 Solna

Ethics committee country [1] 290192 0
Sweden
Date submitted for ethics approval [1] 290192 0
03/09/2007
Approval date [1] 290192 0
01/10/2007
Ethics approval number [1] 290192 0
2007/84-31/1.

Summary
Brief summary
Low plasma glutamine concentration (< 420 micromol/L) is an independent risk factor for mortality in critically ill adult patients. Glutamine metabolism in children is less well characterized. However, the PICU mortality is low and therefore mortality is difficult to use as an endpoint. Here we evaluated if plasma glutamine concentration at admission to the PICU relates to the development of multiple organ failure, using PELOD-score as a surrogate marker of mortality. In this observational study, consecutive critically ill children (n = 149) admitted to the PICU of a tertiary university hospital as well as a reference group of healthy children (n=60) were included. Plasma glutamine concentration and the pediatric logistic organ dysfunction score (PELOD) were determined at admission and at day 5 for patients still in the PICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44418 0
Dr Urban Flaring
Address 44418 0
Department of Pediatric Anaesthesia and Intensive care
Karolinska University Hospital
17176
Stockholm
Country 44418 0
Sweden
Phone 44418 0
+46851770394
Fax 44418 0
Email 44418 0
urban.flaring@karolinska.se
Contact person for public queries
Name 44419 0
Dr Urban Flaring
Address 44419 0
Department of Pediatric Anaesthesia and Intensive care
Karolinska University Hospital
17176
Stockholm
Country 44419 0
Sweden
Phone 44419 0
+46851770394
Fax 44419 0
Email 44419 0
urban.flaring@karolinska.se
Contact person for scientific queries
Name 44420 0
Dr Urban Flaring
Address 44420 0
Department of Pediatric Anaesthesia and Intensive care
Karolinska University Hospital
17176
Stockholm
Country 44420 0
Sweden
Phone 44420 0
+46851770394
Fax 44420 0
Email 44420 0
urban.flaring@karolinska.se

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary