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Register:	ANZCTR
Last refreshed on:	13 January 2020
Main ID:	ACTRN12616001119482
Date of registration:	17/08/2016
Prospective Registration:	No
Primary sponsor:	Karolinska University Hospital
Public title:	Characterization of selenium and glutathione status in critically ill children.
Scientific title:	Characterization of selenium and glutathione status in critically ill children.
Date of first enrolment:	04/04/2014
Target sample size:	160
Recruitment status:	Completed
URL:	https://anzctr.org.au/ACTRN12616001119482.aspx
Study type:	Observational
Study design:	Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Prospective;
Phase:	Not Applicable

Countries of recruitment
Sweden

Contacts

Name:	Dr Urban Flaring
Address:	Department of Pediatric Anaesthesia and Intensive Care Astrid Lindgrens Childrens' Hospital Karolinska University Hospital 17176 Stockholm Sweden Sweden
Telephone:	+46 8 51770394
Email:	urban.flaring@karolinska.se
Affiliation:

Name:	Dr Urban Flaring
Address:	Department of Pediatric Anaesthesia and Intensive Care Astrid Lindgrens Childrens' Hospital Karolinska University Hospital 17176 Stockholm Sweden Sweden
Telephone:	+46 8 51770394
Email:	urban.flaring@karolinska.se
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: <18 years of age; BW >1000 grams; expected time in PICU >24 hours

Exclusion criteria: BW <1000 grams; Age >= 18 years; Expected time in PICU <24 hours; moribund patient

Age minimum: No limit
Age maximum: 18 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Inflammatory and Immune System - Other inflammatory or immune system disorders

Critically ill;
Critically ill

Intervention(s)

Serum selenium concentration and glutathione status will be measured at admission and at day 5 in critically ill children and newborns.

Primary Outcome(s)

Characterize serum Selenium concentration at admission to Intensive care and at day five.[Day 5 compared to Admission (Day 1).]

Investigate if Serum Glutathione status at Admission and day five is linked to serum Selenium concentration.[Day 5 compared to admission (Day 1).]

Secondary Outcome(s)

Organ failure assessment according to PELOD Score at Admission and day five, and correlation to serum Selenium concentration.[Day 5 compared to admission (Day 1).]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Karolinska University Hospital

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

The Regional Ethical Review Board in Stockholm

Results

Results available:
Date Posted:
Date Completed:
URL:

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