title: Safety and efficacy of intensive intraoperative glycaemic control in cardiopulmonary bypass surgery: a randomised trial.
abstract: BACKGROUND
  This study aimed to determine the safety and efficacy of intraoperative intensive glycaemic treatment with modified glucose-insulin-potassium solution by hyperinsulinemic normoglycaemic clamp in cardiopulmonary bypass surgery patients. We hypothesised that the treatment would reduce infection rates in this group of patients.
  
  
  METHODS
  A prospective, randomised, double-blind trial was conducted in cardiopulmonary bypass surgery patients. A total of 199 adult patients (out of a planned 400) were randomly allocated to intensive or conventional treatment with target glucose levels of 4.4-8.3 mmol/l and < 13.8 mmol/l, respectively. The primary outcomes were clinical infection and cytokine levels, including interleukin (IL)-6 and IL-10. The secondary outcomes were morbidity and mortality.
  
  
  RESULTS
  The study was terminated early because of safety concerns (hypoglycaemia). The clinical post-operative infection rate was 17% in the intensive group and 13% in the conventional group (P = 0.53). The proportion of patients with hypoglycaemia was significantly higher in the intensive group (23%) compared with the conventional group (3%) (P < 0.001). Morbidity and mortality rates were similar for both groups. Anaesthetic duration > 2 h (vs. ≤ 2 h), pre-operative IL-6 level > 15 pg/ml (vs. ≤ 15 pg/ml) and post-operative IL-6 level 56-110 pg/ml (vs. ≤ 55 pg/ml) were independent predictors for post-operative infection.
  
  
  CONCLUSIONS
  Intraoperative intensive glycaemic treatment significantly increased the risk of hypoglycaemia, but its effect on post-operative infection by clinical assessment could not be determined. Anaesthetic duration, pre-operative and post-operative IL-6 levels can independently predict post-operative infection.
authors.affiliation: Department of Anesthesiology, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkhla, Thailand.
authors.forename: P
authors.initials: P
authors.lastname: Rujirojindakul
authors.forename: T
authors.initials: T
authors.lastname: Liabsuetrakul
authors.forename: E
authors.initials: E
authors.lastname: McNeil
authors.forename: T
authors.initials: T
authors.lastname: Chanchayanon
authors.forename: W
authors.initials: W
authors.lastname: Wasinwong
authors.forename: M
authors.initials: M
authors.lastname: Oofuvong
authors.forename: C
authors.initials: C
authors.lastname: Rergkliang
authors.forename: V
authors.initials: V
authors.lastname: Chittithavorn
mesh_terms: D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D002318:Cardiovascular Diseases / Q000209:etiology / Q000517:prevention & control; D055499:Catheter-Related Infections / Q000209:etiology; D002405:Catheterization, Central Venous / Q000009:adverse effects; D001026:Coronary Artery Bypass; D003428:Cross Infection / Q000209:etiology; D016207:Cytokines / Q000097:blood; D003920:Diabetes Mellitus / Q000097:blood; D004198:Disease Susceptibility; D005260:Female; D005947:Glucose / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015309:Glucose Clamp Technique / Q000009:adverse effects / Q000379:methods; D006801:Humans; D006943:Hyperglycemia / Q000150:complications / Q000188:drug therapy / Q000517:prevention & control*; D007003:Hypoglycemia / Q000517:prevention & control*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007430:Intraoperative Care / Q000379:methods*; D007431:Intraoperative Complications / Q000188:drug therapy / Q000517:prevention & control*; D007674:Kidney Diseases / Q000209:etiology / Q000517:prevention & control; D007902:Length of Stay; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000209:etiology / Q000517:prevention & control; D011188:Potassium / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D016207:Cytokines; D007328:Insulin; C030396:glucose-insulin-potassium cardioplegic solution; D005947:Glucose; D011188:Potassium