Condition category
Injury, Occupational Diseases, Poisoning
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
02/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Ivan Timofeev

ORCID ID

Contact details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544183600

Study information

Scientific title

Acronym

Study hypothesis

This study aims to establish whether strict control of blood glucose, which has many benefits for critically ill, can be safely applied to patients with brain trauma without causing negative influence on brain glucose levels and energy state. This will be done by comparing the effects of strict glucose control and current 'loose' control on brain chemistry and energy production.

As of 19/05/2011 the anticipated end date for this trial has been extended from 01/08/2007 to 01/08/2011.

Ethics approval

Cambridgeshire 2 Research Ethics Committee on 25/08/2006 (Ref.06/Q0108/215)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

PIS at: http://www.medschl.cam.ac.uk/anaesthetics/wp-content/uploads/2010/02/Blood-sugar-consultee-information-sheet-150310.pdf

Condition

Injury, Occupational Diseases, Poisoning: Traumatic brain injury

Intervention

High blood sugar (glucose) levels are common during critical illness and are strongly linked to poor outcome. Large scale study has now demonstrated that strict control of blood glucose with insulin can reduce the risk of death and complications and improve recovery in surgical intensive care patients. However, after head injury glucose is the most important nutrient required by the brain. The energy demands of the injured brain are higher than those in the normal brain and strictly normal blood glucose levels acceptable for general intensive care patients may be too low for a patient with severe head injury. If injured brain does not receive enough glucose its energy production could deteriorate which may put brain at risk of further injury or delayed recovery. This study aims to establish whether strict control of blood glucose, which has many benefits for the critically ill, can be safely applied to patients with brain trauma without causing negative influences on brain. This will be done by comparing the effects of strict glucose control and current “loose” control on brain chemistry and energy production, assessed using monitoring devices, all of which are in the routine clinical use.
The study will be performed prospectively and will involve 30 patients.
Patients will be randomly (by chance) divided into two groups.
In the first group of patients strict maintenance of normal blood sugar will continue for the first 24 hours and then the current protocol ('loose control') will be used for the following 24 hours.
In the second group of patients the order of the treatment protocols will be reverse (ie initial 24 hours of current 'loose' control will be followed by 24 hours of strict normoglycaemia). The whole duration of the study for the individual patient will be 48 hours. Monitoring parameters, that represent brain metabolism and which are routinely captured at the bedside will be used to compare the effects of two blood sugar control protocols. Appropriate statistical methods will be applied to detect significant differences.
If there is no difference in brain monitoring parameters between strict normoglycaemia and current protocols the former will be considered to be safe to use in patients with head injury and will replace our current protocol for glucose control. However, if the study demonstrates that strict normoglycaemia has an adverse effect on brain metabolism it will be avoided in future in patients with head injury and current ('loose control') protocol will continue to be used.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Differences in cerebral monitoring parameters between current 'loose' and intensive glycaemic control periods. Parameters used for comparison will include, cerebral extracellular glucose, lactate, pyruvate, lactate to pyruvate ratio (LP), glutamate and glycerol; brain tissue oxygen (PbO2) and intracranial pressure.
2. Glucose levels in each protocol group and the frequency of episodes of hypoglycaemia and hyperglycaemia.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2006

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Traumatic brain injury requiring intensive care management with intracranial pressure monitoring
2. Age = 16 years old
3. Absence of exclusion criteria

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

30

Participant exclusion criteria

1. Insulin Dependent Diabetes Mellitus
2. Life threatening injury (not expected to survive > 48 hrs)
3. Pregnancy

Recruitment start date

01/08/2006

Recruitment end date

01/08/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes