Design of the study: ​

• Prospective, Randomized

​

Methods:

• 980 children, ages 0-36 months of age

•Undergone cardiopulmonary bypass

•Patients randomly assigned to tight glycemic control (targe glucose level of 80-110 mg per deciliter) or standard care in cardiac ICU

• Continuous glucose monitoring to detect impending hypoglycemia

• Primary outcome: rate of health care-associated infections

• Secondary outcome: mortality, length of stay, organ failure, hypoglycemia

​

Results:

• 440/490 (91%) children assigned to tight glycemic control group

• 9/490 (2%) assigned to standard care group

• Normoglycemia achieved earlier with tight glycemic control group than with standard care (6 hours vs. 16 hours, P<0.001)

• Normoglycemia maintained for a greater proportion of critical illness (50% vs 33%, P >0.001)

• No significant decrease in rate of health care associated infections

• Secondary outcomes did not differ significantly

• Tight glycemic control did not benefit high risk subgroups

• 3% of patients assigned to tight glycemic control had severe hypoglycemia (blood glucose <40 mg per deciliter)

​

Conclusions:

• Tight glycemic control can be achieved quickly and with a low hypoglycemia rate (3%) after cardiac surgery in children who undergo bypass.

• Tight glycemic control does NOT significantly alter infection rate, mortality, length of stay, organ failure as compared with standard care

​

Other interesting points: ​

• Mortality is an inadequate end point because in this patient population, deaths are largely attributed to underlying cardiac anatomy and quality of surgical repair.

• In contrast to previous trials involving adults, this study showed no benefit of tight glycemic control in critically ill children who had undergone cardiac surgery.

• This study was not blinded.

​

Take home message: ​

• Tight glycemic control (80 – 110 mg per deciliter) did not change the rate of health care associated infections, mortality, or length of stay in the cardiac ICU as compared to standard care.