Effect of Intensive Insulin Therapy on Clinical Prognosis of Infants Undergoing Cardiac Surgery

• Biochemical markers of myocardial injury(troponin and creatine kinase MB) [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Acute renal failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Respiratory failure [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• ICU and hospital length of stay, and ICU readmissions [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Stroke and reversible ischemic neurologic deficit [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Cardiac Index [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Inotropic Scores [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
• Perioperative complications [ Time Frame: average 1 month during the hospitalization ] [ Designated as safety issue: Yes ]
  Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias

The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.

Previous studies showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical and medical intensive care patients. Blood sugar control with intravenous insulin may improve prognosis of patients undergoing cardiac surgery. It is not clear what the best insulin regimen is or what is the best blood sugar target in these patients. So far, most of researches have focused on adult patients but little on infants. The current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of infants undergoing cardiac surgery. On admission, patients will be randomly assigned to either strict normalization of blood glucose ( 110-150 mg/dl) with intensive insulin therapy or the conventional approach, in which blood glucose levels are maintained between 150 and 180 mg/dl.

• Other: Intensive insulin therapy
  Titration of the IV insulin rate for glucose goal 110-150 mg/dL
• Other: Conventional insulin therapy
  Titration of the IV insulin rate for glucose goal 150-180 mg/dl

• Active Comparator: Intensive insulin therapy
  Intensive insulin therapy(Blood glucose target: 110-150 mg/dL)
  Intervention: Other: Intensive insulin therapy
• Active Comparator: Conventional insulin therapy
  Conventional insulin therapy(Blood glucose target: 150-180 mg/dl)
  Intervention: Other: Conventional insulin therapy

Inclusion Criteria:

• Infants underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

• Therapy restricted upon admission
• Preoperative liver or kidney disease or dysfunction
• Preoperative coagulation disorder
• Palliative operation or a second operation
• Type 1 diabetes
• Type 2 diabetes