Intensive Care Clinical Trial
Official title:
Randomized Study to Evaluate the Efficacy and Safety of Two Endovenous Insulin Protocols and a Subcutaneous Insulin Protocol in Critically Ill Patients
To evaluate the efficacy and safety of three insulin algorithms in medical ICU patients (MICU).
Strict glycemic control has been recommended for critically ill patients. However, its
implementation may face difficulties with increased nursing workload, inadequate glucose
control and higher risk of hypoglycemia.
We designed a computer guided protocol to adjust endovenous insulin infusion aiming glucose
levels between 100mg/dl and 130 mg/dl. This trial evaluates the efficacy and safety of this
protocol (algorithm A), compared to a standard endovenous insulin infusion protocol
(algorithm B) and a conventional subcutaneous insulin protocol (algorithm C).
Methods : MICU patients with at least one blood glucose ≥ 150 mg/dL and who are on
mechanical ventilation, or had SIRS, or are admitted because of trauma or burn will be
randomized to one of the following treatments: algorithm A - continuous insulin infusion
with adjustments guided by hand held device or desktop software targeting glucose levels
between 100mg/dL-130mg/dL; algorithm B - continuous insulin aiming glucose levels between
80mg/dl-110mg/dl using Van den Berghe's insulin protocol; algorithm C - conventional
treatment - intermittent subcutaneous administration of insulin if blood glucose levels
exceeds 150mg/dL; insulin will be administered as IV boluses in hypotensive patients.
The randomization list was generated in blocks of six by computer software. Patients will be
randomly assigned in a 1:1:1 ratio to have their glucose controlled by one of the three
insulin algorithms with the use of a central, computerized system accessed by Internet,
permitting concealment of allocation list. Randomization will be stratified according to
study site.
The study is planned to enroll 165 patients in order to have 80% power to detect a 20mg/dl
difference in blood glucose means between groups, assuming standard deviation equal to 33
mg/dl and two-tailed alpha equal to 0.05. Efficacy will be measured by the mean of patients'
median blood glucose and safety measured by the incidence of hypoglycemia (≤40 mg/dL).
Analysis will follow the intention-to-treat principle.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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