Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001119482
Ethics application status
Approved
Date submitted
7/02/2016
Date registered
17/08/2016
Date last updated
17/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Characterization of selenium and glutathione status in critically ill children.
Scientific title
Characterization of selenium and glutathione status in critically ill children.
Secondary ID [1] 288485 0
Nil known
Universal Trial Number (UTN)
U1111-1179-2507
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill 297539 0
Condition category
Condition code
Inflammatory and Immune System 297738 297738 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum selenium concentration and glutathione status will be measured at admission and at day 5 in critically ill children and newborns.
Intervention code [1] 293835 0
Not applicable
Comparator / control treatment
Healthy children set up for elective surgery will be sampled for serum Selenium concentration and glutathione status after induction of anesthesia.
Control group
Active

Outcomes
Primary outcome [1] 297268 0
Characterize serum Selenium concentration at admission to Intensive care and at day five.
Timepoint [1] 297268 0
Day 5 compared to Admission (Day 1).
Primary outcome [2] 297269 0
Investigate if Serum Glutathione status at Admission and day five is linked to serum Selenium concentration.
Timepoint [2] 297269 0
Day 5 compared to admission (Day 1).
Secondary outcome [1] 320539 0
Organ failure assessment according to PELOD Score at Admission and day five, and correlation to serum Selenium concentration.
Timepoint [1] 320539 0
Day 5 compared to admission (Day 1).

Eligibility
Key inclusion criteria
<18 years of age; BW >1000 grams; expected time in PICU >24 hours
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
BW <1000 grams; Age >= 18 years; Expected time in PICU <24 hours; moribund patient

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
T test, Mann-Withney U test, Wilcoxon, Kruskal-Wallis, one-way ANOVA, and Tukeys post hoc test.
At the time the study was planned there was no available data regarding the variation in selenium concentration in critically ill children. In addition, in Sweden there is no information of the selenium concentration in healthy children. Sixty healthy patients were used as controls/reference.. This information was crucial for the study and also important to know since the soil in Sweden has a low content of selenium and to evaluate if the selenium concentration was age dependent.
The main reason for choosing 100 critically ill patients was to generate a sufficient number of patients at day 5. In Scandinavian PICUs approximately 30 % of the patients have a PICU-stay > 5 days. The median stay is 2 days. We only included patients with an expected PICU-stay of > 2 days. Therefore, we expected 45/100 patients with a PICU-stay > 5 days.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/04/2014
Date of last participant enrolment
Anticipated
Actual
8/04/2015
Date of last data collection
Anticipated
15/04/2015
Actual
5/05/2015
Sample size
Target
160
Accrual to date
Final
160
Recruitment outside Australia
Country [1] 7576 0
Sweden
State/province [1] 7576 0

Funding & Sponsors
Funding source category [1] 292834 0
Hospital
Name [1] 292834 0
Karolinska University Hospital
Country [1] 292834 0
Sweden
Primary sponsor type
Hospital
Name
Karolinska University Hospital
Address
FoUU-enheten
Karolinska Universitetssjukhuset/Karolinska University Hopsital
17176 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 291574 0
None
Name [1] 291574 0
Address [1] 291574 0
Country [1] 291574 0
Other collaborator category [1] 278805 0
Individual
Name [1] 278805 0
Prof Jan Wernerman
Address [1] 278805 0
AnOpIVA Clinic
Plan 3 K32/B32
Karolinska University Hospital
141 86 Stockholm
Sweden
Country [1] 278805 0
Sweden
Other collaborator category [2] 278806 0
Individual
Name [2] 278806 0
Prof Olav Rooyackers
Address [2] 278806 0
Dept of Clinical Science, Intervention and Technology (CLINTEC), H9
Dept Anesthesia
Karolinska University Hospital, K32
141 86 Stockholm
Sweden
Country [2] 278806 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294338 0
The Regional Ethical Review Board in Stockholm
Ethics committee address [1] 294338 0
Nobels vag 9,D3
171 65 Solna
Ethics committee country [1] 294338 0
Sweden
Date submitted for ethics approval [1] 294338 0
Approval date [1] 294338 0
04/02/2014
Ethics approval number [1] 294338 0
EPN 2013/2110-31/3

Summary
Brief summary
Reduced serum selenium concentration is common in adult critically ill patients and correlates to increased morbidity and mortality. Parallel supplementation has in a few studies shown reduced mortality rate and less infectious complications. Pediatric critically ill have not been studied and normal values for Scandinavian pediatric population is not known. Selenium supplementation in premature neonatal have shown less infectious complications. In this study we aim to characterize the normal serum concentration of selenium in healthy children to be commenced for elective surgery (n=60). In parallel pediatric critically ill including newborns (n=100) will be characterized concerning selenium- and glutathione status. This approach might reveal anti-oxidative capacity and mechanisms. Secondary aims are to investigate if the selenium- and glutathione profiles correlate to length of stay and severity of illness (PELOD, PIM2).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63326 0
Dr Urban Flaring
Address 63326 0
Department of Pediatric Anaesthesia and Intensive Care
Astrid Lindgrens Childrens' Hospital
Karolinska University Hospital
17176 Stockholm
Sweden
Country 63326 0
Sweden
Phone 63326 0
+46 8 51770394
Fax 63326 0
Email 63326 0
[email protected]
Contact person for public queries
Name 63327 0
Dr Urban Flaring
Address 63327 0
Department of Pediatric Anaesthesia and Intensive Care
Astrid Lindgrens Childrens' Hospital
Karolinska University Hospital
17176 Stockholm
Sweden
Country 63327 0
Sweden
Phone 63327 0
+46 8 51770394
Fax 63327 0
Email 63327 0
[email protected]
Contact person for scientific queries
Name 63328 0
Dr Urban Flaring
Address 63328 0
Department of Pediatric Anaesthesia and Intensive Care
Astrid Lindgrens Childrens' Hospital
Karolinska University Hospital
17176 Stockholm
Sweden
Country 63328 0
Sweden
Phone 63328 0
+46 8 51770394
Fax 63328 0
Email 63328 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

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