Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Cardiac Surgery
- Sponsor
- Xijing Hospital
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- All cause mortality
- Last Updated
- 14 years ago
Overview
Brief Summary
The investigators sought to determine whether intensive insulin therapy can improve prognosis of infants undergoing cardiac surgery.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
All cause mortality
Time Frame: one year
Secondary Outcomes
- Cardiac Index(average 1 month during the hospitalization)
- Biochemical markers of myocardial injury(troponin and creatine kinase MB)(average 1 month during the hospitalization)
- Acute renal failure(average 1 month during the hospitalization)
- Respiratory failure(average 1 month during the hospitalization)
- ICU and hospital length of stay, and ICU readmissions(average 1 month during the hospitalization)
- Stroke and reversible ischemic neurologic deficit(average 1 month during the hospitalization)
- Inotropic Scores(average 1 month during the hospitalization)
- Perioperative complications(average 1 month during the hospitalization)