Normothermia Versus Hypothermia for Valvular Surgery Patients

Study Overview
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Brief Summary
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Cardiopulmonary bypass (CPB) has been used successfully for cardiac surgery for over half a century. Hypothermia became a ubiquitous practice for adult patients undergoing CPB. To date, most studies have been conducted in coronary artery bypass graft (CABG) patients with conflicting results. Current evidence does not support one temperature management strategy for all patients. The purpose of this study is to compare the efficiency and safety of normothermic versus hypothermic CPB in valvular surgery patients.

Official Title
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Normothermia Versus Hypothermia for Patients With Valvular Heart Disease Operated Under Cardiopulmonary Bypass.

Conditions
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Valvular Heart Disease

Intervention / Treatment
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* Procedure: Hypothermic CPB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Isolated heart valve surgery Heart valve surgery plus CABG Age 20-80 Exclusion Criteria: urgent operation Left ventricle ejection fraction < 35% Decompensated congestive heart failure Chronic renal failure (glomerular filtration rate < 60 ml/min) Severe hepatic and pulmonary disease Bleeding diathesis or history of coagulopathy Planed deep hypothermic circulatory arrest History of acute myocardial infarction in the last 3 month Preoperative core temperature >37oC

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Normothermic CPB<br>Standard management. Patients will be kept at normothermia throughout the procedure (>36oC). | |
| Active Comparator: Hypothermic CPB<br>Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC. | Procedure: Hypothermic CPB<br>* Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Troponin I release |  | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for Inotropic Support |  | First 48 postoperative hours | 
| Rate of Perioperative Myocardial Infarction |  | First 48 postoperative hours | 
| Rate of Type I and Type II neurological injury |  | 7 postoperative days | 
| Rate of Dialysis-dependent acute renal failure |  | 7 postoperative days | 
| Rate of infectious complications |  | 30 postoperative days | 
| Total units of Red Blood Cells transfused |  | 7 postoperative days | 
| Intensive Care Unit length of stay |  | 30 postoperative days | 
| Hospital length of stay |  | 30 postoperative days | 
| Rate of In-hospital mortality |  | 30 postoperative days | 
| NT-proBNP release |  | First 24 postoperative hours | 
| Bleeding from chest tubes |  | First 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding