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Tight Glycemic Control With Intensive Insulin Therapy in PICU

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Katholieke Universiteit Leuven.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Greet Van den Berghe, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT00214916
First received: September 19, 2005
Last updated: August 24, 2011
Last verified: August 2011

September 19, 2005
August 24, 2011
October 2004
February 2008   (final data collection date for primary outcome measure)
  • 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 ]
Reduction of inflammation
Complete list of historical versions of study NCT00214916 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Stay in ICU
  • Duration mechanical ventilation
  • Organ failure
Not Provided
Not Provided
 
Tight Glycemic Control With Intensive Insulin Therapy in PICU
KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

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.

Study type: Interventional study

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Critical Illness
  • 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
  • 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
  • Active Comparator: A
    conventional insulin therapy (using Actrapid IV)
    Intervention: Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
  • Experimental: B
    intensive insulin therapy (using actrapid IV)
    Intervention: Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
700
February 2012
February 2008   (final data collection date for primary outcome measure)

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
Both
up to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00214916
PICU-insulin study
Yes
Greet Van den Berghe, Katholieke Universiteit Leuven
Greet Van den Berghe
Not Provided
Study Director: Greet Van den Berghe, MD,PhD Catholic University Leuven
Katholieke Universiteit Leuven
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP