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Critical IllnessPhase 2NCT00214916

Tight Glycemic Control With Intensive Insulin Therapy in PICU

A Phase 2 study testing intensive insulin therapy (Actrapid IV to normoglycemia) and conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) in people with Critical Illness, run by Greet Van den Berghe at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 16 years
Conditions the study is for
Critical Illness
What is being tested?
intensive insulin therapy (Actrapid IV to normoglycemia) and conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteBelgium
Study dates
Oct 2004to Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Dep Intensive Care Medicine University Hospital Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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.

Read the detailed description

Study type: Interventional study

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

Being tested
intensive insulin therapy (Actrapid IV to normoglycemia), conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
Keywords
Tight glycemic control with, intensive insulin treatment, versus conventional glycemic control, in infant or child in ICU
Medical subject headings
Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intensive insulin therapy (Actrapid IV to normoglycemia)Drug

    Also called Actrapid IV to normoglycemia

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

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

    Also called Actrapid IV only for excessive hyperglycemia

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

Study groups in NCT00214916
Study groupRoleWhat they receive
AActive comparatorconventional insulin therapy (using Actrapid IV)
Receives: Drug: conventional insulin therapy (Actrapid IV only for excessive hyperglycemia)
BExperimentalintensive insulin therapy (using actrapid IV)
Receives: Drug: intensive insulin therapy (Actrapid IV to normoglycemia)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction of inflammation

    Measured: during ICU stay to day 5

  2. duration of dependency on intensive care (days in ICU)

    Measured: time in ICU

Secondary outcomes (4)

  1. Duration mechanical ventilation

    Measured: during time in ICU

  2. Organ failure/need for organ support

    Measured: during time in ICU

  3. mortality (safety endpoint)

    Measured: during time in ICU

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

    Measured: 3 years (+/- 6 months) after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionFeb 2008
  4. Study completionJun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00214916
Sponsor's protocol ID
PICU-insulin study
Other IDs
NCT00214916
Status last verified
Mar 2022
First submitted
19 Sep 2005
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 11794168

  • 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.

    PubMed 26667027

  • 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.

    PubMed 26568832

  • 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.

    PubMed 23101118

  • 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.

    PubMed 22872689

  • 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.

    PubMed 21632816

  • 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.

    PubMed 20609741

  • 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.

    PubMed 19176240

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intensive insulin therapy (Actrapid IV to normoglycemia) and conventional insulin therapy (Actrapid IV only for excessive hyperglycemia) in people with Critical Illness, run by Greet Van den Berghe at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of inflammation (time frame: during ICU stay to day 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00214916, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.

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