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Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.

ABSTRACT: BACKGROUND:Hyperinsulinemic normoglycemia augments myocardial glucose uptake and utilization. We tested the hypothesis that hyperinsulinemic normoglycemia reduces 30-day mortality and morbidity after cardiac surgery. METHODS:This dual-center, parallel-group, superiority trial randomized cardiac surgical patients between August 2007 and March 2015 at the Cleveland Clinic, Cleveland, Ohio, and Royal Victoria Hospital, Montreal, Canada, to intraoperative glycemic management with (1) hyperinsulinemic normoglycemia, a fixed high-dose insulin and concomitant variable glucose infusion titrated to glucose concentrations of 80 to 110?mg · dl; or (2) standard glycemic management, low-dose insulin infusion targeting glucose greater than 150?mg · dl. The primary outcome was a composite of 30-day mortality, mechanical circulatory support, infection, renal or neurologic morbidity. Interim analyses were planned at each 12.5% enrollment of a maximum 2,790 patients. RESULTS:At the third interim analysis (n = 1,439; hyperinsulinemic normoglycemia, 709, standard glycemic management, 730; 52% of planned maximum), the efficacy boundary was crossed and study stopped per protocol. Time-weighted average glucose concentration (means ± SDs) with hyperinsulinemic normoglycemia was 108?±?20 versus 150?±?33?mg · dl with standard glycemic management, P < 0.001. At least one component of the composite outcome occurred in 49 (6.9%) patients receiving hyperinsulinemic normoglycemia versus 82 (11.2%) receiving standard glucose management (P < efficacy boundary 0.0085); estimated relative risk (95% interim-adjusted CI) 0.62 (0.39 to 0.97), P = 0.0043. There was a treatment-by-site interaction (P = 0.063); relative risk for the composite outcome was 0.49 (0.26 to 0.91, P = 0.0007, n = 921) at Royal Victoria Hospital, but 0.96 (0.41 to 2.24, P = 0.89, n = 518) at the Cleveland Clinic. Severe hypoglycemia (less than 40?mg · dl) occurred in 6 (0.9%) patients. CONCLUSIONS:Intraoperative hyperinsulinemic normoglycemia reduced mortality and morbidity after cardiac surgery. Providing exogenous glucose while targeting normoglycemia may be preferable to simply normalizing glucose concentrations.

SUBMITTER: Duncan AE

PROVIDER: S-EPMC6509049 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.

Duncan Andra E AE Sessler Daniel I DI Sato Hiroaki H Sato Tamaki T Nakazawa Keisuke K Carvalho George G Hatzakorzian Roupen R Codere-Maruyama Takumi T Abd-Elsayed Alaa A Bose Somnath S Said Tamer T Mendoza-Cuartas Maria M Chowdary Hyndhavi H Mascha Edward J EJ Yang Dongsheng D Gillinov A Marc AM Schricker Thomas T

Anesthesiology 20180601 6

<h4>Background</h4>Hyperinsulinemic normoglycemia augments myocardial glucose uptake and utilization. We tested the hypothesis that hyperinsulinemic normoglycemia reduces 30-day mortality and morbidity after cardiac surgery.<h4>Methods</h4>This dual-center, parallel-group, superiority trial randomized cardiac surgical patients between August 2007 and March 2015 at the Cleveland Clinic, Cleveland, Ohio, and Royal Victoria Hospital, Montreal, Canada, to intraoperative glycemic management with (1) ...[more]

PMID: 29537981

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Project description:IntroductionNew financial incentives, such as reduced Medicare reimbursements, have led hospitals to closely monitor their readmission rates and initiate efforts aimed at reducing them. In this context, many surgical departments participate in the American College of Surgeons National Surgical Quality Improvement Program (NSQIP), which collects detailed demographic, laboratory, clinical, procedure and perioperative occurrence data. The availability of such data enables the development of data science methods which predict readmissions and, as done in this paper, offer specific recommendations aimed at preventing readmissions.Materials and methodsThis study leverages NSQIP data for 722,101 surgeries to develop predictive and prescriptive models, predicting readmissions and offering real-time, personalized treatment recommendations for surgical patients during their hospital stay, aimed at reducing the risk of a 30-day readmission. We applied a variety of classification methods to predict 30-day readmissions and developed two prescriptive methods to recommend pre-operative blood transfusions to increase the patient's hematocrit with the objective of preventing readmissions. The effect of these interventions was evaluated using several predictive models.ResultsPredictions of 30-day readmissions based on the entire collection of NSQIP variables achieve an out-of-sample accuracy of 87% (Area Under the Curve-AUC). Predictions based only on pre-operative variables have an accuracy of 74% AUC, out-of-sample. Personalized interventions, in the form of pre-operative blood transfusions identified by the prescriptive methods, reduce readmissions by 12%, on average, for patients considered as candidates for pre-operative transfusion (pre-operative hematoctic <30). The prediction accuracy of the proposed models exceeds results in the literature.ConclusionsThis study is among the first to develop a methodology for making specific, data-driven, personalized treatment recommendations to reduce the 30-day readmission rate. The reported predicted reduction in readmissions can lead to more than $20 million in savings in the U.S. annually.

Dataset Information

Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.

Publications

Hyperinsulinemic Normoglycemia during Cardiac Surgery Reduces a Composite of 30-day Mortality and Serious In-hospital Complications: A Randomized Clinical Trial.

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