Control of hyperglycaemia in paediatric intensive care

Not Applicable

Completed

Conditions: Signs and Symptoms
Hyperglycaemia
Elevated blood glucose level

Registration Number: ISRCTN61735247

Lead Sponsor: Royal Brompton & Harefiled NHS Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 1500

Inclusion Criteria

Children from birth to 16 years who are undergoing intensive care treatment with an arterial line in-situ and receiving both mechanical ventilation and vasoactive support drugs following injury, major surgery or in association with critical illness in whom it is anticipated such treatment will be required to continue for at least 12 hours.

Exclusion Criteria

1. Children born pre-term and who are < 36 weeks corrected gestation
2. Children with diabetes mellitus
3. Children with an established or suspected diagnosis of an inborn error of metabolism
4. Children for whom treatment withdrawal or limitation of intensive care treatment is being considered
5. Children who have been in a PICU for more than 5 days in succession
6. Children admitted to a PICU who have already participated in the CHIP study during a previous PICU admission

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of days alive and free from mechanical ventilation within the 30 days after trial entry. Death is obviously an important outcome. Mechanical ventilation can be seen as a measure of disease severity, defining the need for complex intensive care. The concept of ventilator free days (Vedas) brings together these two outcomes. Schoenfeld et al define ventilator free days (VFDs) as: VFD=0 if the child dies before 30 days; VDF=(30-x) if the child is successfully weaned from ventilator within 30 days (where x is the no. of days on ventilator); or VFD=0 if the child is ventilated for 30 days or more. The use of organ failure free days to determine patient-related morbidity surrogate end-points in paediatric trials has been supported by influential paediatric trialists in the current low mortality paediatric critical care environment.

Secondary Outcome Measures