Cerebral metabolic effects of strict normoglycaemia versus current clinical glycaemic control following severe traumatic brain injury

ISRCTN	ISRCTN19146279
DOI	https://doi.org/10.1186/ISRCTN19146279
Secondary identifying numbers	N0544183600

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 29/01/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Mr Ivan Timofeev
Scientific

Addenbrooke's Hospital
Hills Road
London
SW3 6NP
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	PIS at: http://www.medschl.cam.ac.uk/anaesthetics/wp-content/uploads/2010/02/Blood-sugar-consultee-information-sheet-150310.pdf
Scientific title	Cerebral metabolic effects of strict normoglycaemia versus current clinical glycaemic control following severe traumatic brain injury
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.
Ethics approval(s)	Cambridgeshire 2 Research Ethics Committee, 25/08/2006, ref: 06/Q0108/215
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
Primary outcome measure	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 study start date	01/08/2006
Overall study end date	01/08/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	Not Specified
Target number of participants	30
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 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

England
United Kingdom

Study participating centre

Addenbrooke's Hospital

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	25/01/2018		Yes	No

Editorial Notes

29/01/2018: Publication reference added.
19/05/2011: The overall trial end date was changed from 01/08/2007 to 01/08/2011.