Tight Glycemic Control With Intensive Insulin Therapy in PICU

Conditions

Critical Illness

Keywords

Tight glycemic control with, intensive insulin treatment, versus conventional glycemic control, in infant or child in ICU

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

Verstraete S, Vanhorebeek I, Covaci A, Güiza F, Malarvannan G, Jorens PG, Van den Berghe G.

2015-12-1444 citations

10.1007/s00134-015-4159-5

Neurocognition after paediatric heart surgery: a systematic review and meta-analysis.

Sterken C, Lemiere J, Vanhorebeek I, Van den Berghe G, Mesotten D.

2015-10-2918 citations

10.1136/openhrt-2015-000255

Neurocognitive development of children 4 years after critical illness and treatment with tight glucose control: a randomized controlled trial.

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.

2012-10-01122 citations

10.1001/jama.2012.12424

Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study.

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.

2009-01-26379 citations

10.1016/s0140-6736(09)60044-1

Interventions

DRUGintensive insulin therapy (Actrapid IV to normoglycemia)

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

DRUGconventional 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Days to 16 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Reduction of inflammation	during ICU stay to day 5
duration of dependency on intensive care (days in ICU)	time in ICU

Secondary

Measure	Time frame
long-term follow-up study : focus on neurocognitive development (ethical approval granted)	3 years (+/- 6 months) after randomization
Duration mechanical ventilation	during time in ICU
Organ failure/need for organ support	during time in ICU
mortality (safety endpoint)	during time in ICU

Countries

Belgium

Outcome results

None listed