Date of this Version
Pediatric Critical Care Medicine
Objectives: To describe the design of a clinical trial testing the hypothesis that children randomized to tight glycemic control with intensive insulin therapy after cardiac surgery will have improved clinical outcomes compared to children randomized to conventional blood glucose management.
Design: Two-center, randomized controlled trial.
Setting: Cardiac ICUs at two large academic pediatric centers.
Patients: Children from birth to those aged 36 months recovering in the cardiac ICU after surgery with cardiopulmonary bypass.
Interventions: Subjects in the tight glycemic control (intervention) group receive an intravenous insulin infusion titrated to achieve normoglycemia (target blood glucose range of 80–110 mg/dL; 4.4–6.1 mmol/L). The intervention begins at admission to the cardiac ICU from the operating room and terminates when the patient is ready for discharge from the ICU. Continuous glucose monitoring is performed during insulin infusion to minimize the risks of hypoglycemia. The standard care group has no target blood glucose range.
Measurements and Main Results: The primary outcome is the development of any nosocomial infection (bloodstream, urinary tract, and surgical site infection or nosocomial pneumonia). Secondary outcomes include mortality, measures of cardiorespiratory function and recovery, laboratory indices of nutritional balance, immunologic, endocrinologic, and neurologic function, cardiac ICU and hospital length of stay, and neurodevelopmental outcome at 1 and 3 yrs of age. A total of 980 subjects will be enrolled (490 in each treatment arm) for sufficient power to show a 50% reduction in the prevalence of the primary outcome.
Conclusions: Pediatric cardiac surgery patients may recognize great benefit from tight glycemic control in the postoperative period, particularly with regard to reduction of nosocomial infections. The Safe Pediatric Euglycemia after Cardiac Surgery trial is designed to provide an unbiased answer to the question of whether this therapy is indeed beneficial and to define the associated risks of therapy.
This is a non-final version of an article published in final form in Pediatric Critical Care Medicine. 2013 February ; 14(2): 148–156. doi:10.1097/PCC.0b013e31825b549a
cardiac surgery, children, critical illness/therapy, hyperglycemia/drug therapy, insulin/therapeutic use
Gaies, M. G., Langer, M., Alexander, J., Steil, G. M., Ware, J., Wypij, D., Laussen, P. C., Newburger, J. W., Goldberg, C. S., Pigula, F. A., Shukla, A. C., Duggan, C. P., Agus, M. D., & Curley, M. A. (2013). Design and Rationale of Safe Pediatric Euglycemia After Cardiac Surgery (SPECS): A Randomized Controlled Trial of Tight Glycemic Control After Pediatric Cardiac Surgery. Pediatric Critical Care Medicine, 14 (2), 148-156. http://dx.doi.org/10.1097/PCC.0b013e31825b549a
Date Posted: 01 June 2016
This document has been peer reviewed.