title: Strict glycaemic control in patients hospitalised in a mixed medical and surgical intensive care unit: a randomised clinical trial.
abstract: BACKGROUND
  Critically 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  Over 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 (< or = 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).
  
  
  CONCLUSIONS
  IIT 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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifiers: 4374-04-13031; 094-2 in 000966421.
authors.affiliation: Department of Critical Care, Hospital Pablo Tobon Uribe, Calle 78B 69-240, Medellin, Colombia. giseladlr@une.net.co
authors.forename: Gisela Del Carmen
authors.initials: Gdel C
authors.lastname: De La Rosa
authors.forename: Jorge Hernando
authors.initials: JH
authors.lastname: Donado
authors.forename: Alvaro Humberto
authors.initials: AH
authors.lastname: Restrepo
authors.forename: Alvaro Mauricio
authors.initials: AM
authors.lastname: Quintero
authors.forename: Luis Gabriel
authors.initials: LG
authors.lastname: González
authors.forename: Nora Elena
authors.initials: NE
authors.lastname: Saldarriaga
authors.forename: Marisol
authors.initials: M
authors.lastname: Bedoya
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Toro
authors.forename: Jorge Byron
authors.initials: JB
authors.lastname: Velásquez
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Valencia
authors.forename: Clara Maria
authors.initials: CM
authors.lastname: Arango
authors.forename: Pablo Henrique
authors.initials: PH
authors.lastname: Aleman
authors.forename: Esdras Martin
authors.initials: EM
authors.lastname: Vasquez
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Chavarriaga
authors.forename: Andrés
authors.initials: A
authors.lastname: Yepes
authors.forename: William
authors.initials: W
authors.lastname: Pulido
authors.forename: Carlos Alberto
authors.initials: CA
authors.lastname: Cadavid
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000378:metabolism; D003422:Critical Care / Q000379:methods* / Q000592:standards*; D005260:Female; D038321:Glycemic Index / Q000502:physiology*; D006760:Hospitalization; D006801:Humans; D007328:Insulin / Q000097:blood; D007362:Intensive Care Units / Q000592:standards*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D007328:Insulin
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