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Insulin therapy in critically ill children with hyperglycemia: clinical and biochemical characteristics.


- candidate number8200
- NTR NumberNTR2400
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2010
- Secondary IDs 
- Public TitleInsulin therapy in critically ill children with hyperglycemia: clinical and biochemical characteristics.
- Scientific TitleInsulin therapy in critically ill children with hyperglycemia: clinical and biochemical characteristics.
- ACRONYM
- hypothesisThe objective of the present study is to investigate the endogenous insulin response in critically ill children with hyperglycemia in relation with clinical factors and hormonal, metabolic and immunologic parameters.
- Healt Condition(s) or Problem(s) studiedInsulin sensitivy, Children, Hyperglycemia, Critically ill children
- Inclusion criteriaCritically ill children aged 2 weeks to 18 years consecutively admitted to the PICU of the Erasmus MC-Sophia Childrenís Hospital with hyperglycemia (defined as blood glucose level exceeding the value of 8 mmol/L (>145 mg/dL)) at any time during admission meeting the criteria for insulin treatment.
- Exclusion criteriaChildren with diabetes mellitus are excluded.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jan-2006
- planned closingdate1-jan-2011
- Target number of participants60
- InterventionsAnthropometric measurements are taken on the day of admission. Blood glucose measurements are obtained as soon as possible after admission. In case of hyperglycemia >8 mmol/L (>145 mg/dL) measurements are repeated every hour and further according to the protocol. Blood is collected from an indwelling arterial or venous catheter or from capillary puncture.
At the start of insulin therapy arterial blood samples for the determination of glucose, insulin, cortisol, C-reactive protein (CRP), lactate, cholesterol, free fatty acids (FFA), triglycerides, creatinin, urea, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and prothrombin time (PT) are taken.
- Primary outcomeEndogenous and exogenous factors influencing the endogenous insulin response to hyperglycemia.
- Secondary outcomeEndogenous and exogenous factors influencing the duration of insulin therapy.
- TimepointsFrom start of insulin therapy till the stop of treatment, parameters are collected once a day.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES
- CONTACT for SCIENTIFIC QUERIES
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Sophia Children's Hospital
- PublicationsManagement of hyperglycemia in the pediatric intensive care unit; implementation of a glucose control protocol. Jennifer J Verhoeven, Jeannette B Brand, Miirjam M van de Polder, Koen FM Joosten. PCCM 2009 Vol 10, No6.
- Brief summaryN/A
- Main changes (audit trail)
- RECORD2-jul-2010 - 11-jul-2010


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