None listed
Conditions
Brief summary
Intravenous insulin is commonly used to maintain normoglycaemic in the Christchurch Hospital Intensive Care Unit (ICU). The current standard protocol, SPRINT, uses intravenous insulin injections every 1-2 hours and controls the blood glucose levels very effectively. However, once patients leave the ICU, the standard protocols in the general wards are to use subcutaneous insulin, often due to the lack of intravenous lines and nursing resource. Currently, the guidelines for switching patients from intravenous to subcutaneous insulin are unclear, resulting in inconsistent levels of care. Therefore ward patients do not continue to benefit from tight blood glucose control. There is a need for a system, which can maintain good blood glucose control outside of ICU that can follow patients from ICU to less acute wards, while keeping nursing effort to a minimum. This study will first validate the Glargine pharmacokinetics model developed by the investigator’s group and test the effectiveness of Glargine as basal insulin support in the ICU populations. These steps are necessary before expending glycaemic control to less acute wards.
Interventions
Recovering critically ill patients who meets the study inclusion criteria will be given insulin glargine once a day. The dose will be determined by a titration algorithm. Blood samples will be taken for assays of plasma insulin and C-peptide 3 times a day for the first two days a patient is receiving glargine. The samples will be taken before glargine injection, 6 hours from time of injection, and 14 hours from time of injection. The patient will continue to receive glargine for blood glucose co
Recovering critically ill patients who meets the study inclusion criteria will be given insulin glargine once a day. The dose will be determined by a titration algorithm. Blood samples will be taken for assays of plasma insulin and C-peptide 3 times a day for the first two days a patient is receiving glargine. The samples will be taken before glargine injection, 6 hours from time of injection, and 14 hours from time of injection. The patient will continue to receive glargine for blood glucose control unless the dose become less than 10U. When the patient begins to consume meals (as oppose to naso-gastric feed), blood samples will be taken 8 times a day for the first two days. These samples will be taken before glargine injection and breakfast, before lunch, before dinner, 30 mins from start of dinner, 1 hr from start of dinner, 1.5 hrs from start of dinner, 2 hrs from start of dinner, and 4 hrs from start of dinner. Photos will be taken of the meal before and after mealtime to determine nutrition intake.
Sponsors
Canterbury District Health Board/Christchurch Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
- Stable hourly insulin requirement, equal to or less than 3U of intravenous insulin per hour, for at least 12 hours. - Stable naso-gastric feed rate, equal to or greater than 60% of the calculated goal feed. (Goal feed is calculated using individual patient’s age, gender and frame size.) - No acute renal failure (creatinine < 250 micromol/L) - Less than 1000ml of fluid given as intravenous boluses in the past 24 hours, indicating stable interstitial volume. - Resolving multiple organ failure (Sequential Organ Failure Assessment Score SOFA<=6).
Exclusion criteria
insulin dependent diabetes, absence of an arterial line, not expected to survive for more than 3 days at the time of screening
Outcome results
None listed