Condition category
Signs and Symptoms
Date applied
23/01/2007
Date assigned
24/01/2007
Last edited
02/05/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.chip-trial.org.uk

Contact information

Type

Scientific

Primary contact

Dr Duncan Macrae

ORCID ID

Contact details

Director of Paediatrics
Royal Brompton Hospital
Sydney Street
London
SW3 6NP
United Kingdom
d.macrae@rbht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 05/506/03; 2006PC008B

Study information

Scientific title

Acronym

CHIP

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.

Ethics approval

Brighton East REC. Date of approval: 01/06/2007 (ref: 07/Q1907/24)

Study design

Randomised, controlled, interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hyperglycaemia

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

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)

Overall trial start date

01/02/2007

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

1,500

Participant 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

Recruitment start date

01/02/2007

Recruitment end date

30/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Director of Paediatrics
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Royal Brompton & Harefiled NHS Trust (United Kingdom)

Sponsor details

Sydney Street
London
SW3 6NP
United Kingdom
m.cross@rbht.nhs.uk

Sponsor type

Government

Website

http://www.rbht.nhs.uk

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Macrae D, Pappachan J, Grieve R, Parslow R, Nadel S, Schindler M, Baines P, Fortune PM, Slavik Z, Goldman A, Truesdale A, Betts H, Allen E, Snowdon C, Percy D, Broadhead M, Quick T, Peters M, Morris K, Tasker R, Elbourne D, Control of hyperglycaemia in paediatric intensive care (CHiP): study protocol., BMC Pediatr, 2010, 10, 5, doi: 10.1186/1471-2431-10-5.

  2. Results

    Macrae D, Grieve R, Allen E, Sadique Z, Morris K, Pappachan J, Parslow R, Tasker RC, Elbourne D, , A randomized trial of hyperglycemic control in pediatric intensive care., N. Engl. J. Med., 2014, 370, 2, 107-118, doi: 10.1056/NEJMoa1302564.

  3. Results

    Macrae D, Grieve R, Allen E, Sadique Z, Betts H, Morris K, Pappachan VJ, Parslow R, Tasker RC, Baines P, Broadhead M, Duthie ML, Fortune PM, Inwald D, McMaster P, Peters MJ, Schindler M, Guerriero C, Piercy D, Slavik Z, Snowdon C, Van Dyck L, Elbourne D, A clinical and economic evaluation of Control of Hyperglycaemia in Paediatric intensive care (CHiP): a randomised controlled trial., Health Technol Assess, 2014, 18, 26, 1-210, doi: 10.3310/hta18260.

Additional files

Editorial Notes