Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.

Detailed Description
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There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).

Official Title
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Study of the Relationship Between Rewarming Rate During Cardiopulmonary Bypass and Clinical Prognosis in Infants Undergoing Cardiac Surgery

Conditions
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Cardiac Surgery, Cardiopulmonary Bypass, Rewarming Rate

Intervention / Treatment
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* Other: Slow rewarming strategy
* Other: Fast rewarming strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infants who had underwent cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Preoperative liver or kidney disease or dysfunction Preoperative coagulation disorder Palliative operation or a second operation Above 3 years

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Slow rewarming strategy<br>Slow rewarming strategy (0.24 degrees C/min) | Other: Slow rewarming strategy<br>* Rewarming rate:0.24 degrees C/min.<br>|
| Active Comparator: Fast rewarming strategy<br>Fast rewarming strategy (0.5 degrees C/min) | Other: Fast rewarming strategy<br>* Rewarming rate:0.5 degrees C/min.<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 |
| --- | --- | --- |
| Acute renal failure |  | one month | 
| Respiratory failure |  | one month | 
| ICU and hospital length of stay, and ICU readmissions |  | one month | 
| Stroke and reversible ischemic neurologic deficit |  | one month | 
| Measures of inflammation | Measures of inflammation (C-reactive protein, TNF-alpha; IL-6) and oxidative stress markers | one month | 
| Biochemical markers of myocardial necrosis | Biochemical markers of myocardial necrosis（troponin and creatine kinase MB） | one month | 
| Perioperative complications | Perioperative complications include sternal wound infection (deep and superficial), bacteremia, pneumonia, and major cardiovascular events (acute myocardial infarction, congestive heart failure, and cardiac arrhythmias. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Prognosis, Cardiac Surgery, Rewarming Rate