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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014