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Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery.
Pediatr Crit Care Med. 2013 Feb; 14(2):148-56.PC

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, MI, USA. mgaies@med.umich.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

22805161

Citation

Gaies, Michael G., et al. "Design and Rationale of Safe Pediatric Euglycemia After Cardiac Surgery: a Randomized Controlled Trial of Tight Glycemic Control After Pediatric Cardiac Surgery." Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, vol. 14, no. 2, 2013, pp. 148-56.
Gaies MG, Langer M, Alexander J, et al. Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery. Pediatr Crit Care Med. 2013;14(2):148-56.
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. S. (2013). Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery. Pediatric Critical Care Medicine : a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 14(2), 148-56. https://doi.org/10.1097/PCC.0b013e31825b549a
Gaies MG, et al. Design and Rationale of Safe Pediatric Euglycemia After Cardiac Surgery: a Randomized Controlled Trial of Tight Glycemic Control After Pediatric Cardiac Surgery. Pediatr Crit Care Med. 2013;14(2):148-56. PubMed PMID: 22805161.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery. AU - Gaies,Michael G, AU - Langer,Monica, AU - Alexander,Jamin, AU - Steil,Garry M, AU - Ware,Janice, AU - Wypij,David, AU - Laussen,Peter C, AU - Newburger,Jane W, AU - Goldberg,Caren S, AU - Pigula,Frank A, AU - Shukla,Avinash C, AU - Duggan,Christopher P, AU - Agus,Michael S D, AU - ,, PY - 2012/7/19/entrez PY - 2012/7/19/pubmed PY - 2013/9/17/medline SP - 148 EP - 56 JF - Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies JO - Pediatr Crit Care Med VL - 14 IS - 2 N2 - 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. SN - 1529-7535 UR - https://www.unboundmedicine.com/medline/citation/22805161/Design_and_rationale_of_safe_pediatric_euglycemia_after_cardiac_surgery:_a_randomized_controlled_trial_of_tight_glycemic_control_after_pediatric_cardiac_surgery_ L2 - https://doi.org/10.1097/PCC.0b013e31825b549a DB - PRIME DP - Unbound Medicine ER -