ACTRN12616001135404
Terminated
Phase 2
iberal glUcose Control in critically Ill patients with pre-existing type 2 Diabetes (LUCID): a phase II multicentre randomised controlled trial to evaluate the prevalence and effect of hypoglycaemia.
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 2 Diabetes
- Sponsor
- Royal Adelaide Hospital
- Enrollment
- 436
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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