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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normothermic CPB | No Intervention | Standard management. Patients will be kept at normothermia throughout the procedure (>36oC). | |
| Hypothermic CPB | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypothermic CPB | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Troponin I release | 48 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir V Lomivorotov, MD, PhD | Research Institute of Pathology of Circulation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Institute of Circulation Patholody | Novosibirsk | 630055 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23962460 | Result | Lomivorotov VV, Shmirev VA, Efremov SM, Ponomarev DN, Moroz GB, Shahin DG, Kornilov IA, Shilova AN, Lomivorotov VN, Karaskov AM. Hypothermic versus normothermic cardiopulmonary bypass in patients with valvular heart disease. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):295-300. doi: 10.1053/j.jvca.2013.03.009. Epub 2013 Aug 17. |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D007035 | Hypothermia |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |