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Safety and efficacy of intensive intraoperative glycaemic control in cardiopulmonary bypass surgery: a randomised trial
Author(s) -
RUJIROJINDAKUL P.,
LIABSUETRAKUL T.,
MCNEIL E.,
CHANCHAYA T.,
WASINWONG W.,
OOFUVONG M.,
RERGKLIANG C.,
CHITTITHAVORN V.
Publication year - 2014
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.12305
Subject(s) - medicine , cardiopulmonary bypass , anesthesia , clinical trial , prospective cohort study , intensive care , randomized controlled trial , cardiac surgery , surgery , insulin , complication , intensive care unit , intensive care medicine
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.