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Control of Hyperglycaemia In Paediatric intensive care
ISRCTN ISRCTN61735247
DOI 10.1186/ISRCTN61735247
ClinicalTrials.gov identifier
EudraCT number
Public title Control of Hyperglycaemia In Paediatric intensive care
Scientific title
Acronym CHIP
Serial number at source HTA 05/506/03; 2006PC008B
Study hypothesis Main hypothesis:
For children aged from birth to 16 years on ventilatory support, tight glucose control (TGC) will increase the numbers of days alive and free of mechanical ventilation at 30 days.

Secondary hypotheses:
That TGC will lead to improvement in a range of non-fatal complications associated with intensive care treatment and be cost effective.
Lay summary Not provided at time of registration
Ethics approval Brighton East REC. Date of approval: 01/06/2007 (ref: 07/Q1907/24)
Study design Randomised, controlled, interventional trial
Countries of recruitment United Kingdom
Disease/condition/study domain Hyperglycaemia
Participants - 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.
Participants - 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
Anticipated start date 01/02/2007
Anticipated end date 30/04/2011
Status of trial Completed
Patient information material
Target number of participants 1,500
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 group only if BG levels exceed 12mmol/l on two blood samples taken at least 30 minutes apart and will be discontinued once BG falls to =< 10 mmol/l.

Group 2 - Tight Glycaemic Control
Children in this group will receive insulin by intravenous infusion titrated to maintain a BG between the limits of 4 and 7.0 mmol/l.
Primary outcome measure(s) 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 measure(s) 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)
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website http://www.chip-trial.org.uk
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/20137090
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24401049
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24780450
Contact name Dr  Duncan  Macrae
  Address Director of Paediatrics
Royal Brompton Hospital
Sydney Street
  City/town London
  Zip/Postcode SW3 6NP
  Country United Kingdom
  Email d.macrae@rbht.nhs.uk
Sponsor Royal Brompton & Harefiled NHS Trust (United Kingdom)
  Address Sydney Street
  City/town London
  Zip/Postcode SW3 6NP
  Country United Kingdom
  Email m.cross@rbht.nhs.uk
  Sponsor website: http://www.rbht.nhs.uk
Date applied 23/01/2007
Last edited 02/05/2014
Date ISRCTN assigned 24/01/2007
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