Tight Glycemic Control With Intensive Insulin Therapy in PICU - Full Text View

Purpose

In a previous study, the investigators showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality in adult intensive care patients. Whether this intervention also improves prognosis of pediatric intensive care patients remains unknown. The current prospective, randomized, controlled study will asses the impact of intensive insulin therapy on outcome of patients in a pediatric intensive care unit. On admission patients will be randomly assigned to either strict normalization of blood glucose according age adjusted values or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl to maintain blood glucose levels between 180-200 mg/dl.

Condition	Intervention	Phase
Critical Illness	Drug: intensive insulin therapy (Actrapid IV to normoglycemia) Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

Resource links provided by NLM:

MedlinePlus related topics: Blood Sugar Diabetes Medicines Hyperglycemia

Drug Information available for: Insulin human

U.S. FDA Resources

Further study details as provided by Katholieke Universiteit Leuven:

Primary Outcome Measures:

Reduction of inflammation [ Time Frame: during ICU stay to day 5 ] [ Designated as safety issue: No ]
duration of dependency on intensive care (days in ICU) [ Time Frame: time in ICU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration mechanical ventilation [ Time Frame: during time in ICU ] [ Designated as safety issue: No ]
Organ failure/need for organ support [ Time Frame: during time in ICU ] [ Designated as safety issue: No ]
mortality (safety endpoint) [ Time Frame: during time in ICU ] [ Designated as safety issue: Yes ]
long-term follow-up study : focus on neurocognitive development (ethical approval granted) [ Time Frame: 3 years (+/- 6 months) after randomization ] [ Designated as safety issue: Yes ]

Enrollment:	700
Study Start Date:	October 2004
Estimated Study Completion Date:	February 2012
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A conventional insulin therapy (using Actrapid IV)	Drug: 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 Name: Actrapid IV only for excessive hyperglycemia
Experimental: B intensive insulin therapy (using actrapid IV)	Drug: intensive insulin therapy (Actrapid IV to normoglycemia) intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia) Other Name: Actrapid IV to normoglycemia

Detailed Description:

Study type: Interventional study

Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study

Eligibility

Ages Eligible for Study:	up to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children admitted to the pediatric intensive care unit and anticipated to require intensive care for at least 24 hours

Exclusion Criteria:

Expected stay < 24 hours
Therapy restriction upon admission
No informed consent
Other study enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00214916

Locations

Belgium
Dep Intensive Care Medicine University Hospital Leuven
Leuven, Belgium, 3000

Sponsors and Collaborators

Greet Van den Berghe

Investigators

Study Director:

Greet Van den Berghe, MD,PhD

Catholic University Leuven

More Information

Publications:

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 the critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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. 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.

Responsible Party:	Greet Van den Berghe, Head of Dept Intensive Care Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:	NCT00214916 History of Changes
Other Study ID Numbers:	PICU-insulin study
Study First Received:	September 19, 2005
Last Updated:	August 24, 2011
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Katholieke Universiteit Leuven:

Tight glycemic control with
intensive insulin treatment
versus conventional glycemic control
in infant or child in ICU

Additional relevant MeSH terms:

Critical Illness
Disease Attributes
Pathologic Processes
Insulin

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013