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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2007
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. Appropri CONDITION: Injury, Occupational Diseases, Poisoning: Traumatic brain injury ; Injury, Occupational Diseases, Poisoning ; Traumatic brain injury PRIMARY OUTCOME: 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: Not provided at time of registration INCLUSION CRITERIA: 1. Traumatic brain injury requiring intensive care management with intracranial pressure monitoring 2. Age = 16 years old 3. Absence of exclusion criteria
Epistemonikos ID: abfa10f1a56c81c5f5a1cd5703fd630addc98e96
First added on: Aug 21, 2024