None listed
Conditions
Brief summary
When patients with diabetes are very unwell (critically ill and admitted to ICU) their blood glucose levels are often higher than previously. This frequently requires the use of insulin which is administered directly into a vein. We are uncertain about how aggressively we should treat these blood glucose levels. Currently, patients with diabetes are treated exactly like all other patients, i.e. persons without diabetes, such that insulin is administered when blood glucose reaches 10 mmol/L and titrated to target a blood glucose less than 10 mmol/L. This approach - called conventional glucose control - may increase the risk of very low blood glucose levels (termed ‘hypoglycaemia’), which is known to be harmful to patients in ICU, and may cause blood glucose levels that are low relative to their normal blood glucose levels before they were sick (termed ‘relative hypoglycaemia’), which may also be harmful. Because intensive care clinicians are uncertain as to which of these approaches is better participants will be randomly assigned, like the flip of a coin, to receive either: Conventional glucose control participants will be treated the same way patients with diabetes usually are, which is exactly like all other patients without diabetes, and insulin will be administered when blood glucose reaches 10 mmol/L with insulin adjusted to target blood concentrations in the range 6-10 mmol/L. OR Liberal glucose control participants will only have insulin administered when their blood glucose is > 14 mmol/L and the insulin will be titrated to target a blood glucose 10-14 mmol/L. We are evaluating whether a more ‘liberal’ approach in patients with diabetes, i.e. insulin in administered when blood glucose is > 14 mmol/L and titrated to target a blood glucose 10-14 mmol/L leads to a reduction in complications that are associated with insulin use and result in better outcomes for patients with diabetes. This approach – called liberal glucose control - isn’t necessarily better, as higher blood glucose levels may increase the risk of developing infections in ICU and could lead to weakness after ICU. This study will include 450 patients who have diabetes and are admitted to ICU. Patients admitted to one of 12 hospitals in Australia or New Zealand will be asked to participate.
Interventions
The intervention will be delivered by an ICU nurse, the insulin will be commenced when blood glucose > 14.0 mmol/L and infusion adjusted to target blood glucose 10-14 mmo/L. Concentrations < 10 mmol/L would not be actively treated with glucose. As per the NICE-SUGAR trial each ICU will be able to use the relevant institutional protocol rather than a standardised protocol.
Treatment will be for the duration of ICU admission until day 28.
Study data will be collected by the sites research nurse an
The intervention will be delivered by an ICU nurse, the insulin will be commenced when blood glucose > 14.0 mmol/L and infusion adjusted to target blood glucose 10-14 mmo/L. Concentrations < 10 mmol/L would not be actively treated with glucose. As per the NICE-SUGAR trial each ICU will be able to use the relevant institutional protocol rather than a standardised protocol. Treatment will be for the duration of ICU admission until day 28. Study data will be collected by the sites research nurse and each site will have a monitoring visit to ensure accurate data collection.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients (aged 18 years or older). Expected to remain in the ICU until the day after tomorrow. Patient has either an arterial or central line in situ, or the placement of an arterial or central line is imminent (within the next hour) as part of routine ICU management. Patient has type 2 diabetes. The treating clinician believes that that there is a reasonable likelihood that a blood glucose concentration greater than or equal to 10 mmol/L will be recorded at some stage during the ICU admission.
Exclusion criteria
Death during ICU admission is deemed to be inevitable. Admitted to the ICU for treatment of diabetic ketoacidosis or hyperosmolar state. Patients who have juvenile type 1 diabetes. Requirement for specific blood glucose target as determined by the treating doctor, i.e. the treating clinician believes either intervention or standard care arms of LUCID would not be in the best interests of the patient Patients expected to be eating before the end of the next calendar day. Patients who have previously suffered hypoglycemia without documented full neurological recovery. Patient cannot provide prior informed consent and there is documented evidence that the patient has no legal surrogate decision maker, and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent. Patient has been in the study ICU or another ICU for greater than or equal to 24 h during the index admission. Patient has previously been enrolled in LUCID. Females who are pregnant or suspected to be pregnant determined by a positive serum or urine human chorionic gonadotropin (hCG) test.
Outcome results
None listed