Design and rationale of safe pediatric euglycemia after cardiac surgery: a randomized controlled trial of tight glycemic control after pediatric cardiac surgery.
OBJECTIVE
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.


METHODS
Two-center, randomized controlled trial.


METHODS
Cardiac ICUs at two large academic pediatric centers.


METHODS
Children from birth to those aged 36 months recovering in the cardiac ICU after surgery with cardiopulmonary bypass.


METHODS
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.


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.
Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital, University of Michigan Medical School, Ann Arbor, MI, USA. mgaies@med.umich.edu
Michael G
MG
Gaies
Monica
M
Langer
Jamin
J
Alexander
Garry M
GM
Steil
Janice
J
Ware
David
D
Wypij
Peter C
PC
Laussen
Jane W
JW
Newburger
Caren S
CS
Goldberg
Frank A
FA
Pigula
Avinash C
AC
Shukla
Christopher P
CP
Duggan
Michael S D
MS
Agus
D001786:Blood Glucose / Q000378:metabolism*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D002315:Cardiopulmonary Bypass; D002675:Child, Preschool; D003422:Critical Care / Q000379:methods*; D003428:Cross Infection / Q000517:prevention & control; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D007223:Infant; D007231:Infant, Newborn; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use*; D057194:Intention to Treat Analysis; D008991:Monitoring, Physiologic; D011182:Postoperative Care; D012107:Research Design; D013530:Surgical Wound Infection / Q000517:prevention & control
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin