Tight Glycemic Control With Intensive Insulin Therapy in PICU
NCT ID: NCT00214916
Last Updated: 2022-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
700 participants
INTERVENTIONAL
2004-10-31
2023-06-30
Brief Summary
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Detailed Description
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Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
conventional insulin therapy (using Actrapid IV)
conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
B
intensive insulin therapy (using actrapid IV)
intensive insulin therapy (Actrapid IV to normoglycemia)
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
Interventions
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intensive insulin therapy (Actrapid IV to normoglycemia)
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Therapy restriction upon admission
* No informed consent
* Other study enrollment
1 Day
16 Years
ALL
No
Sponsors
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Greet Van den Berghe
OTHER
Responsible Party
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Greet Van den Berghe
Head of Dept and laboratory of Intensive Care Medicine
Principal Investigators
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Greet Van den Berghe, MD,PhD
Role: STUDY_DIRECTOR
Catholic University Leuven
Locations
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Dep Intensive Care Medicine University Hospital Leuven
Leuven, , Belgium
Countries
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References
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van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300.
Verstraete S, Vanhorebeek I, Covaci A, Guiza F, Malarvannan G, Jorens PG, Van den Berghe G. Circulating phthalates during critical illness in children are associated with long-term attention deficit: a study of a development and a validation cohort. Intensive Care Med. 2016 Mar;42(3):379-392. doi: 10.1007/s00134-015-4159-5. Epub 2015 Dec 14.
Sterken C, Lemiere J, Vanhorebeek I, Van den Berghe G, Mesotten D. Neurocognition after paediatric heart surgery: a systematic review and meta-analysis. Open Heart. 2015 Oct 29;2(1):e000255. doi: 10.1136/openhrt-2015-000255. eCollection 2015.
Mesotten D, Gielen M, Sterken C, Claessens K, Hermans G, Vlasselaers D, Lemiere J, Lagae L, Gewillig M, Eyskens B, Vanhorebeek I, Wouters PJ, Van den Berghe G. Neurocognitive development of children 4 years after critical illness and treatment with tight glucose control: a randomized controlled trial. JAMA. 2012 Oct 24;308(16):1641-50. doi: 10.1001/jama.2012.12424.
Gielen M, Mesotten D, Wouters PJ, Desmet L, Vlasselaers D, Vanhorebeek I, Langouche L, Van den Berghe G. Effect of tight glucose control with insulin on the thyroid axis of critically ill children and its relation with outcome. J Clin Endocrinol Metab. 2012 Oct;97(10):3569-76. doi: 10.1210/jc.2012-2240. Epub 2012 Aug 7.
Gielen M, Mesotten D, Brugts M, Coopmans W, Van Herck E, Vanhorebeek I, Baxter R, Lamberts S, Janssen JA, Van den Berghe G. Effect of intensive insulin therapy on the somatotropic axis of critically ill children. J Clin Endocrinol Metab. 2011 Aug;96(8):2558-66. doi: 10.1210/jc.2010-3045. Epub 2011 Jun 1.
Vlasselaers D, Mesotten D, Langouche L, Vanhorebeek I, van den Heuvel I, Milants I, Wouters P, Wouters P, Meyns B, Bjerre M, Hansen TK, Van den Berghe G. Tight glycemic control protects the myocardium and reduces inflammation in neonatal heart surgery. Ann Thorac Surg. 2010 Jul;90(1):22-9. doi: 10.1016/j.athoracsur.2010.03.093.
Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
Other Identifiers
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NCT00214916
Identifier Type: -
Identifier Source: secondary_id
PICU-insulin study
Identifier Type: -
Identifier Source: org_study_id
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