title: Tight glycemic control versus standard care after pediatric cardiac surgery.
abstract: BACKGROUND
  In some studies, tight glycemic control with insulin improved outcomes in adults undergoing cardiac surgery, but these benefits are unproven in critically ill children at risk for hyperinsulinemic hypoglycemia. We tested the hypothesis that tight glycemic control reduces morbidity after pediatric cardiac surgery.
  
  
  METHODS
  In this two-center, prospective, randomized trial, we enrolled 980 children, 0 to 36 months of age, undergoing surgery with cardiopulmonary bypass. Patients were randomly assigned to either tight glycemic control (with the use of an insulin-dosing algorithm targeting a blood glucose level of 80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]) or standard care in the cardiac intensive care unit (ICU). Continuous glucose monitoring was used to guide the frequency of blood glucose measurement and to detect impending hypoglycemia. The primary outcome was the rate of health care-associated infections in the cardiac ICU. Secondary outcomes included mortality, length of stay, organ failure, and hypoglycemia.
  
  
  RESULTS
  A total of 444 of the 490 children assigned to tight glycemic control (91%) received insulin versus 9 of 490 children assigned to standard care (2%). Although normoglycemia was achieved earlier with tight glycemic control than with standard care (6 hours vs. 16 hours, P<0.001) and was maintained for a greater proportion of the critical illness period (50% vs. 33%, P<0.001), tight glycemic control was not associated with a significantly decreased rate of health care-associated infections (8.6 vs. 9.9 per 1000 patient-days, P=0.67). Secondary outcomes did not differ significantly between groups, and tight glycemic control did not benefit high-risk subgroups. Only 3% of the patients assigned to tight glycemic control had severe hypoglycemia (blood glucose <40 mg per deciliter [2.2 mmol per liter]).
  
  
  CONCLUSIONS
  Tight glycemic control can be achieved with a low hypoglycemia rate after cardiac surgery in children, but it does not significantly change the infection rate, mortality, length of stay, or measures of organ failure, as compared with standard care. (Funded by the National Heart, Lung, and Blood Institute and others; SPECS ClinicalTrials.gov number, NCT00443599.).
authors.affiliation: Boston Children's Hospital and Harvard Medical School, Boston, MA 02115, USA. michael.agus@childrens.harvard.edu.
authors.forename: Michael S D
authors.initials: MS
authors.lastname: Agus
authors.forename: Garry M
authors.initials: GM
authors.lastname: Steil
authors.forename: David
authors.initials: D
authors.lastname: Wypij
authors.forename: John M
authors.initials: JM
authors.lastname: Costello
authors.forename: Peter C
authors.initials: PC
authors.lastname: Laussen
authors.forename: Monica
authors.initials: M
authors.lastname: Langer
authors.forename: Jamin L
authors.initials: JL
authors.lastname: Alexander
authors.forename: Lisa A
authors.initials: LA
authors.lastname: Scoppettuolo
authors.forename: Frank A
authors.initials: FA
authors.lastname: Pigula
authors.forename: John R
authors.initials: JR
authors.lastname: Charpie
authors.forename: Richard G
authors.initials: RG
authors.lastname: Ohye
authors.forename: Michael G
authors.initials: MG
authors.lastname: Gaies
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D006348:Cardiac Surgical Procedures; D002675:Child, Preschool; D016638:Critical Illness / Q000628:therapy; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy*; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007239:Infections / Q000453:epidemiology; D015278:Intensive Care Units, Pediatric; D057194:Intention to Treat Analysis; D008297:Male; D011183:Postoperative Complications / Q000188:drug therapy*
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents