Abstract
IntroductionCritically ill patients can develop hyperglycaemia even if they do not have diabetes. Intensive insulin therapy decreases morbidity and mortality rates in patients in a surgical intensive care unit (ICU) and decreases morbidity in patients in a medical ICU. The effect of this therapy on patients in a mixed medical/surgical ICU is unknown. Our goal was to assess whether the effect of intensive insulin therapy, compared with standard therapy, decreases morbidity and mortality in patients hospitalised in a mixed ICU.MethodsThis is a prospective, randomised, non-blinded, single-centre clinical trial in a medical/surgical ICU. Patients were randomly assigned to receive either intensive insulin therapy to maintain glucose levels between 80 and 110 mg/dl (4.4 to 6.1 mmol/l) or standard insulin therapy to maintain glucose levels between 180 and 200 mg/dl (10 and 11.1 mmol/l). The primary end point was mortality at 28 days.ResultsOver a period of 30 months, 504 patients were enrolled. The 28-day mortality rate was 32.4% (81 of 250) in the standard insulin therapy group and 36.6% (93 of 254) in the intensive insulin therapy group (Relative Risk [RR]: 1.1; 95% confidence interval [CI]: 0.85 to 1.42). The ICU mortality in the standard insulin therapy group was 31.2% (78 of 250) and 33.1% (84 of 254) in the intensive insulin therapy group (RR: 1.06; 95%CI: 0.82 to 1.36). There was no statistically significant reduction in the rate of ICU-acquired infections: 33.2% in the standard insulin therapy group compared with 27.17% in the intensive insulin therapy group (RR: 0.82; 95%CI: 0.63 to 1.07). The rate of hypoglycaemia (≤ 40 mg/dl) was 1.7% in the standard insulin therapy group and 8.5% in the intensive insulin therapy group (RR: 5.04; 95% CI: 1.20 to 21.12).ConclusionsIIT used to maintain glucose levels within normal limits did not reduce morbidity or mortality of patients admitted to a mixed medical/surgical ICU. Furthermore, this therapy increased the risk of hypoglycaemia.Trial Registrationclinicaltrials.gov Identifiers: 4374-04-13031; 094-2 in 000966421
Highlights
Ill patients can develop hyperglycaemia even if they do not have diabetes
APACHE II: Acute Physiology and Chronic Health Evaluation; CDC: Centers for Disease Control; 95% confidence intervals (CI): 95% confidence interval; HPTU: Hospital Pablo Tobón Uribe; ICU: intensive care unit; IQR: interquartile range; RR: relative risk; SD: standard deviation; SOFA: Sequential Organ Failure Assessment
Observational studies have suggested that strict glucose control is able to reduce hospital mortality in mixed medical/surgical ICUs [7,8], but other non-experimental studies in similar settings have not confirmed that the mean glucose level is an independent risk factor for ICU mortality. [9,10,11]
Summary
Ill patients can develop hyperglycaemia even if they do not have diabetes. A randomised trial of 1548 patients hospitalised in a surgical intensive care unit (ICU) showed that maintaining normal glucose levels reduces morbidity and mortality [5]. In another randomised study of 1200 patients requiring a minimum of three days hospitalisation in a medical ICU, intensive glucose control resulted in a decrease in morbidity but not in total mortality. We conducted a randomised clinical trial to assess the efficacy and safety of intensive insulin therapy compared with standard glucose control in patients hospitalised for medical problems, surgical non-cardiovascular procedures or trauma in a mixed medical/surgical ICU
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