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

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

Detailed Description
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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.

Official Title
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Study of the Relationship Between Intensive Insulin Therapy and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Conditions
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Cardiac Surgery

Intervention / Treatment
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* Other: Intensive insulin therapy
* Other: Conventional insulin therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive insulin therapy<br>Intensive insulin therapy(Blood glucose target: 110-150 mg/dL) | Other: Intensive insulin therapy<br>* Titration of the IV insulin rate for glucose goal 110-150 mg/dL<br>|
| Active Comparator: Conventional insulin therapy<br>Conventional insulin therapy(Blood glucose target: 150-180 mg/dl) | Other: Conventional insulin therapy<br>* Titration of the IV insulin rate for glucose goal 150-180 mg/dl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Cardiac Index |  | average 1 month during the hospitalization | 
| Inotropic Scores |  | 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 | average 1 month during the hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac surgery, prognosis, intensive insulin therapy