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ISRCTN
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ISRCTN68283215
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ClinicalTrials.gov identifier
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Public title
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Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shock
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Scientific title
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Pathophysiological aspects of hyperglycemia in children with meningococcal sepsis and septic shock: a prospective, observational cohort study
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Acronym
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N/A
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Serial number at source
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196429 / 2000 / 222
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Study hypothesis
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The objective of the present study was to investigate the occurrence of hyperglycemia in relation with the insulin response and exogenous factors, such as glucose intake and drug use, in a homogenous group of critically ill children with meningococcal sepsis and/or meningococcal septic shock.
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Lay summary
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Ethics approval
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The Medical Ethics Committee (MEC) approved in March 2000 (ref: 196429 / 2000 / 222)
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Study design
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Prospective observational cohort study
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Meningococcal sepsis
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Participants - inclusion criteria
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The study population consisted of previously healthy children admitted to the Pediatric Intensive Care Unit (PICU) of the Erasmus Medical Centre - Sophia Children’s Hospital between October 1997 and May 2004, suffering from meningococcal sepsis, i.e. sepsis with petechiae/purpura
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Participants - exclusion criteria
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1. Pre-existing endocrine or chromosomal abnormalities
2. Radiation or chemotherapy within the previous 6 months
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Anticipated start date
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01/10/1997
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Anticipated end date
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01/05/2004
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details to request a patient information sheet
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Target number of participants
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80
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Interventions
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Observational cohort study. Blood samples to be taken on admission, and at 24 and 48 hours thereafter.
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Primary outcome measure(s)
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1. Blood glucose levels
2. Plasma levels of
2.1. insulin
2.2. C-peptide
2.3. cortisol
2.4. cytokines
2.5. C-reactive protein (CRP)
2.6. cytokines
Measured on admission, and at 24 and 48 hours.
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Secondary outcome measure(s)
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None
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Sources of funding
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Erasmus Medical Centre, Sophia Children’s Hospital (Netherlands)
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Trial website
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Publications
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Contact name
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Dr
Koen
Joosten
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Address
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Dr Molewaterplein 60
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City/town
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Rotterdam
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Zip/Postcode
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3000CB
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Country
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Netherlands
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Sponsor
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Erasmus Medical Centre, Sophia Children’s Hospital (Netherlands)
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Address
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Dr Molewaterplein 60
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City/town
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Rotterdam
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Zip/Postcode
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3000CB
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Country
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Netherlands
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Date applied
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22/06/2010
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Last edited
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07/07/2010
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Date ISRCTN assigned
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07/07/2010
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