Hyperglycaemia Signs and Symptoms Elevated blood glucose level
Conditions
Interventions
Group 1 - Standard treatment
Children in this group will be treated according to a standard, current, approach to blood glucose (BG) management. Insulin will be given by intravenous infusion in this
Sponsors
Royal Brompton & Harefiled NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Death within 30 days after trial entry (or before discharge from hospital if duration is greater than 30 days) 2. Death within 12 months of trial entry 3. Number of days in ICU 4. Duration of mechanical ventilation 5. Duration of vasoactive drug usage (adrenaline, noradrenaline, dopamine, dobutamine, or phosphodiesterase type III [PDE-III] inhibitors or vasopressors) 6. Need for renal replacement therapy 7. Blood stream infection (positive cultures associated with two or more features of systemic inflammation or any positive blood culture for fungus) 8. Use of antibiotics >10 days 9. Number of red cell transfusions 10. Number of hypoglycaemic episodes moderate (less than 2.5 mmol/L), severe (less than 2.0 mmol/L) 11. Occurrence of seizures (clinical seizures requiring anticonvulsant therapy) 12. Organ dysfunction score (Pediatric Logistic Organ Dysfunction [PELOD]) 13. Hospital length of stay 14. Number of children readmitted within 30 days of trial entry 15. Cost and cost-effectiveness measures: 15.1. Hospital costs within 30 days of trial entry 15.2. Cost per life year (based on 30 days costs and survival) 15.3. Hospital and community health service costs within 12 months of trial entry 15.4. Cost per life year (based on 12 month costs and survival for all cases) 15.5. Cost per disability-free survivor (based on 12 month cost and outcome data for sub group with brain injury) | — |
Countries
United Kingdom
Outcome results
None listed