Tight Glycemic Control With Intensive Insulin Therapy in PICU

Critical Illness Clinical Trial

Official title:

KULeuven Intensive Insulin Study in Pediatric Intensive Care Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00214916
• Other study ID #: PICU-insulin study
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

Study type: Interventional study

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: June 2023
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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

Locations

Country	Name	City	State
Belgium	Dep Intensive Care Medicine University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Greet Van den Berghe

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of inflammation		during ICU stay to day 5
Primary	duration of dependency on intensive care (days in ICU)		time in ICU
Secondary	Duration mechanical ventilation		during time in ICU
Secondary	Organ failure/need for organ support		during time in ICU
Secondary	mortality (safety endpoint)		during time in ICU
Secondary	long-term follow-up study : focus on neurocognitive development (ethical approval granted)		3 years (+/- 6 months) after randomization