Tight Glycemic Control With Intensive Insulin Therapy in PICU
Primary Purpose
Critical Illness
Status
Active
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
intensive insulin therapy (Actrapid IV to normoglycemia)
conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness focused on measuring Tight glycemic control with, intensive insulin treatment, versus conventional glycemic control, in infant or child in ICU
Eligibility 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
Sites / Locations
- Dep Intensive Care Medicine University Hospital Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
conventional insulin therapy (using Actrapid IV)
intensive insulin therapy (using actrapid IV)
Outcomes
Primary Outcome Measures
Reduction of inflammation
duration of dependency on intensive care (days in ICU)
Secondary Outcome Measures
Duration mechanical ventilation
Organ failure/need for organ support
mortality (safety endpoint)
long-term follow-up study : focus on neurocognitive development (ethical approval granted)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00214916
Brief Title
Tight Glycemic Control With Intensive Insulin Therapy in PICU
Official Title
KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2004 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
June 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Greet Van den Berghe
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
Study type: Interventional study
Study design: single centre, prospective, randomized, active control, parallel assignment, efficacy study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Tight glycemic control with, intensive insulin treatment, versus conventional glycemic control, in infant or child in ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
conventional insulin therapy (using Actrapid IV)
Arm Title
B
Arm Type
Experimental
Arm Description
intensive insulin therapy (using actrapid IV)
Intervention Type
Drug
Intervention Name(s)
intensive insulin therapy (Actrapid IV to normoglycemia)
Other Intervention Name(s)
Actrapid IV to normoglycemia
Intervention Description
intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)
Intervention Type
Drug
Intervention Name(s)
conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
Other Intervention Name(s)
Actrapid IV only for excessive hyperglycemia
Intervention Description
conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)
Primary Outcome Measure Information:
Title
Reduction of inflammation
Time Frame
during ICU stay to day 5
Title
duration of dependency on intensive care (days in ICU)
Time Frame
time in ICU
Secondary Outcome Measure Information:
Title
Duration mechanical ventilation
Time Frame
during time in ICU
Title
Organ failure/need for organ support
Time Frame
during time in ICU
Title
mortality (safety endpoint)
Time Frame
during time in ICU
Title
long-term follow-up study : focus on neurocognitive development (ethical approval granted)
Time Frame
3 years (+/- 6 months) after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greet Van den Berghe, MD,PhD
Organizational Affiliation
Catholic University Leuven
Official's Role
Study Director
Facility Information:
Facility Name
Dep Intensive Care Medicine University Hospital Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
11794168
Citation
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.
Results Reference
background
PubMed Identifier
26667027
Citation
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.
Results Reference
derived
PubMed Identifier
26568832
Citation
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.
Results Reference
derived
PubMed Identifier
23101118
Citation
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.
Results Reference
derived
PubMed Identifier
22872689
Citation
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.
Results Reference
derived
PubMed Identifier
21632816
Citation
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.
Results Reference
derived
PubMed Identifier
20609741
Citation
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.
Results Reference
derived
PubMed Identifier
19176240
Citation
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.
Results Reference
derived
Learn more about this trial
Tight Glycemic Control With Intensive Insulin Therapy in PICU
We'll reach out to this number within 24 hrs