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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
800
Titration of the IV insulin rate for glucose goal 110-150 mg/dL
Titration of the IV insulin rate for glucose goal 150-180 mg/dl
Xijing Hospital
Xi'an, Shaanxi, China
All cause mortality
Time frame: one year
Biochemical markers of myocardial injury(troponin and creatine kinase MB)
Time frame: average 1 month during the hospitalization
Acute renal failure
Time frame: average 1 month during the hospitalization
Respiratory failure
Time frame: average 1 month during the hospitalization
ICU and hospital length of stay, and ICU readmissions
Time frame: average 1 month during the hospitalization
Stroke and reversible ischemic neurologic deficit
Time frame: average 1 month during the hospitalization
Cardiac Index
Time frame: average 1 month during the hospitalization
Inotropic Scores
Time frame: average 1 month during the hospitalization
Perioperative complications
Perioperative complications including sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias
Time frame: average 1 month during the hospitalization
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