Endothelial Dysfunction and Selenium Status in Children With Acute Systemic Inflammatory Response
1 other identifier
observational
114
1 country
1
Brief Summary
The overall hypotheses of this project is that severe sepsis is associated with endothelial dysfunction in pediatric patients and that selenium deficiency is associated with changes in biological markers of endothelial dysfunction and that these changes, in turn, are associated with worse clinical prognosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 22, 2016
June 1, 2016
5 months
August 3, 2015
June 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
association between selenium status and the endothelial activation
To investigate the association between selenium status and the endothelial activation in children during acute systemic inflammatory response.
30/06/2016 (up to 2 years)
Secondary Outcomes (1)
Endothelial activation and clinical outcome in children with SIRS
30/06/2016 (up to 2 years)
Eligibility Criteria
children admitted to an intensive care unit (ICU) with systemic inflammatory response.
You may qualify if:
- All patients admitted to an intensive care unit with systemic inflammatory response
You may not qualify if:
- Blood transfusion
- Chronic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emílio Lopes Junior
São Paulo, São Paulo, 05579-000, Brazil
Related Publications (2)
Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.
PMID: 23353941BACKGROUNDGoldstein B, Giroir B, Randolph A; International Consensus Conference on Pediatric Sepsis. International pediatric sepsis consensus conference: definitions for sepsis and organ dysfunction in pediatrics. Pediatr Crit Care Med. 2005 Jan;6(1):2-8. doi: 10.1097/01.PCC.0000149131.72248.E6.
PMID: 15636651BACKGROUND
Biospecimen
blood
Study Officials
- STUDY DIRECTOR
Heitor Pons Leite, professor
Federal University of São Paulo
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- post graduate
Study Record Dates
First Submitted
August 3, 2015
First Posted
December 2, 2015
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
June 22, 2016
Record last verified: 2016-06