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Tight Glycemic Control With Intensive Insulin Therapy in PICU

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ClinicalTrials.gov Identifier: NCT00214916
Recruitment Status : Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Critical Illness Drug: intensive insulin therapy (Actrapid IV to normoglycemia) Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) Phase 2

Detailed Description:

Study type: Interventional study

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


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
Study Start Date : October 2004
Primary Completion Date : February 2008
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Reduction of inflammation [ Time Frame: during ICU stay to day 5 ]
  2. duration of dependency on intensive care (days in ICU) [ Time Frame: time in ICU ]

Secondary Outcome Measures :
  1. Duration mechanical ventilation [ Time Frame: during time in ICU ]
  2. Organ failure/need for organ support [ Time Frame: during time in ICU ]
  3. mortality (safety endpoint) [ Time Frame: during time in ICU ]
  4. long-term follow-up study : focus on neurocognitive development (ethical approval granted) [ Time Frame: 3 years (+/- 6 months) after randomization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Greet Van den Berghe, Head of Dept and laboratory of Intensive Care Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT00214916     History of Changes
Other Study ID Numbers: PICU-insulin study
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Greet Van den Berghe, 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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs