A randomized controlled trial comparing a computer-assisted insulin protocol with a strict and conventional protocol for glucose control in critically ill patients

Intensive Care Unit, Hospital Israelita Albert Einstein, São Paulo 05652-000, Brazil.
Journal of critical care (Impact Factor: 2). 07/2009; 24(3):371-8. DOI: 10.1016/j.jcrc.2009.05.005
Source: PubMed

ABSTRACT The objective of this study is to evaluate blood glucose (BG) control efficacy and safety of 3 insulin protocols in medical intensive care unit (MICU) patients.
This was a multicenter randomized controlled trial involving 167 MICU patients with at least one BG measurement >or=150 mg/dL and one or more of the following: mechanical ventilation, systemic inflammatory response syndrome, trauma, or burns. The interventions were computer-assisted insulin protocol (CAIP), with insulin infusion maintaining BG between 100 and 130 mg/dL; Leuven protocol, with insulin maintaining BG between 80 and 110 mg/dL; or conventional treatment-subcutaneous insulin if glucose >150 mg/dL. The main efficacy outcome was the mean of patients' median BG, and the safety outcome was the incidence of hypoglycemia (<or=40 mg/dL).
The mean of patients' median BG was 125.0, 127.1, and 158.5 mg/dL for CAIP, Leuven, and conventional treatment, respectively (P = .34, CAIP vs Leuven; P < .001, CAIP vs conventional). In CAIP, 12 patients (21.4%) had at least one episode of hypoglycemia vs 24 (41.4%) in Leuven and 2 (3.8%) in conventional treatment (P = .02, CAIP vs Leuven; P = .006, CAIP vs conventional).
The CAIP is safer than and as effective as the standard strict protocol for controlling glucose in MICU patients. Hypoglycemia was rare under conventional treatment. However, BG levels were higher than with IV insulin protocols.

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    • "Some of the 36 studies were conducted in more than one country, but most studies were conducted in the United States [16-20,22,23,25-27,29,31,32,36-39,42,44,46-48,50] (61%, 22/36), followed by the Netherlands [34,35,41,43] (11%, 4/36), the United Kingdom [28,30,33] (8%, 3/36), Germany [40,45] and New Zealand [14,21] (6% each, 2/36), and Australia [24], Brazil [49], Canada [44], Denmark [28], Israel [40], Italy [40], Lithuania [15], Norway [28], and Portugal [28] (3% each, 1/36). Fifty-eight percent of the studies reported solely public funding [16,17,19,23,25-30,33,35,37-42,46-48,50], 8% (3/36) reported solely private funding [21,22,36], 6% (2/36) reported both private and public funding [24,49], and 28% (10/36) did not report their funding source [14,15,18,20,31,32,34,43-45]. "
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    Implementation Science 08/2011; 6(1):91. DOI:10.1186/1748-5908-6-91 · 4.12 Impact Factor
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    • "Additional file 3, Table S3 shows the characteristics of the 33 included RCTs [4-39]. A total of 24,627 patients were included, including one study with 13,219 patients and only six other studies [19,21,26-28,31,34-37] with more than 500 patients. "
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