NCT00214916

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
15.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

3.3 years

First QC Date

September 19, 2005

Last Update Submit

March 8, 2022

Conditions

Critical Illness

Keywords

Tight glycemic control withintensive insulin treatmentversus conventional glycemic controlin infant or child in ICU

Outcome Measures

Primary Outcomes (2)

  • Reduction of inflammation

    during ICU stay to day 5

  • duration of dependency on intensive care (days in ICU)

    time in ICU

Secondary Outcomes (4)

  • Duration mechanical ventilation

    during time in ICU

  • Organ failure/need for organ support

    during time in ICU

  • mortality (safety endpoint)

    during time in ICU

  • long-term follow-up study : focus on neurocognitive development (ethical approval granted)

    3 years (+/- 6 months) after randomization

Study Arms (2)

A

ACTIVE COMPARATOR

conventional insulin therapy (using Actrapid IV)

Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)

B

EXPERIMENTAL

intensive insulin therapy (using actrapid IV)

Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

Interventions

intensive insulin therapy (Actrapid IV to normoglycemia)DRUG

intensive insulin therapy (Actrapid IV in continuous infusion to age-dependent normoglycemia)

Also known as: Actrapid IV to normoglycemia
B
conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)DRUG

conventional insulin therapy (Actrapid IV in continuous infusion only to treat blood glucose levels exceeding 220 mg/dl)

Also known as: Actrapid IV only for excessive hyperglycemia
A

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep Intensive Care Medicine University Hospital Leuven

Leuven, 3000, Belgium

Location

Related Publications (8)

  • 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.

    PMID: 11794168BACKGROUND

  • 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.

    PMID: 26667027DERIVED

  • 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.

    PMID: 26568832DERIVED

  • 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.

    PMID: 23101118DERIVED

  • 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.

    PMID: 22872689DERIVED

  • 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.

    PMID: 21632816DERIVED

  • 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.

    PMID: 20609741DERIVED

  • 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.

    PMID: 19176240DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Greet Van den Berghe, MD,PhD

    Catholic University Leuven

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Dept and laboratory of Intensive Care Medicine

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

October 1, 2004

Primary Completion

February 1, 2008

Study Completion

June 1, 2023

Last Updated

March 10, 2022

Record last verified: 2022-03

Locations

BE(1)