E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020635 |
E.1.2 | Term | Hyperglycaemia |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal objective of the proposed trial is to determine whether a policy of Tight Control of Blood Glucose (BG) levels using insulin to maintain normal blood glucose concentration, results in improved clinical outcomes without impairing safety in children who require intensive care during critical illness or following major cardiac surgery. This will be in comparison to current standard treatment protocols which allow permissive hyperglycaemia (higher than normal levels of blood glucose). |
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E.2.2 | Secondary objectives of the trial |
That tight blood glucose control will lead to a reduction in a range of complications associated with intensive care treatment and be cost effective |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Brain Injury sub-group - 13th February 2007 Version 1 Follow-up of Traumatic Brain Injury sub-group This sub-group is more likely to have longer-term morbidity and parents of children (aged 4 or over) in this sub-group will be asked to provide additional information at 12 months, regarding overall health status, global neurological outcome, attention and behavioural status .
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E.3 | Principal 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. |
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E.4 | Principal exclusion criteria |
Children born pre-term and who are < 36 weeks corrected gestation Children with diabetes mellitus Children with an established or suspected diagnosis of an inborn error of metabolism Children for whom treatment withdrawal or limitation of intensive care treatment is being considered Children who have been in a PICU for more than 5 days in succession Children admitted to a PICU who have already participated in the CHIP study during a previous PICU admission.
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E.5 End points |
E.5.1 | Primary end point(s) |
Following the influential ARDSNET study we will use as the primary outcome 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as when the last patient recruited has completed their scheduled involvement in the trial i.e. last follow-up vist. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |