Valvular Heart Disease
Conditions
Keywords
Cardiopulmonary Bypass, Hypothermia, Normothermia, Troponin I, Bleeding
Brief summary
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.
Interventions
PROCEDUREHypothermic CPB
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
Sponsors
Meshalkin Research Institute of Pathology of Circulation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiac Troponin I release | 48 hours |
Secondary
| Measure | 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 |
Countries
Russia
Outcome results
None listed