OBJECTIVE: The aim of this study was to test the hypothesis that normothermic cardiopulmonary bypass (CPB) is as effective as hypothermic CPB in terms of cardiac protection (cTnI level) and outcome in patients with valvular heart disease. DESIGN: Prospective randomized study. SETTING: A tertiary cardiothoracic referral center. PARTICIPANTS: 140 patients who had valvular heart disease, with/without coronary artery disease, surgically treated under CPB. INTERVENTIONS: The patients were allocated randomly to undergo either hypothermic (temperature [T], 31 °C-32 °C) or normothermic CPB (T>36 °C). MEASUREMENTS AND MAIN RESULTS: The primary endpoint was the dynamics of troponin I. The secondary endpoints were ventilation time, the need for inotropic support, intensive care unit (ICU) and hospital stay durations, complications, and mortality. There were no significant intergroup differences in dynamics of troponin I. Ventilation time was significantly lower in the hypothermic group (6 (5-9) and 8 (5-12); p = 0.01). CONCLUSIONS:Normothermic CPB in patients with valvular heart disease was as effective as hypothermic perfusion in terms of myocardial protection after the surgery assessed by cTnI release. The short ventilation duration in patients who underwent hypothermic CPB needs to be confirmed in a future investigation.
RCT Entities:
OBJECTIVE: The aim of this study was to test the hypothesis that normothermic cardiopulmonary bypass (CPB) is as effective as hypothermic CPB in terms of cardiac protection (cTnI level) and outcome in patients with valvular heart disease. DESIGN: Prospective randomized study. SETTING: A tertiary cardiothoracic referral center. PARTICIPANTS: 140 patients who had valvular heart disease, with/without coronary artery disease, surgically treated under CPB. INTERVENTIONS: The patients were allocated randomly to undergo either hypothermic (temperature [T], 31 °C-32 °C) or normothermic CPB (T>36 °C). MEASUREMENTS AND MAIN RESULTS: The primary endpoint was the dynamics of troponin I. The secondary endpoints were ventilation time, the need for inotropic support, intensive care unit (ICU) and hospital stay durations, complications, and mortality. There were no significant intergroup differences in dynamics of troponin I. Ventilation time was significantly lower in the hypothermic group (6 (5-9) and 8 (5-12); p = 0.01). CONCLUSIONS: Normothermic CPB in patients with valvular heart disease was as effective as hypothermic perfusion in terms of myocardial protection after the surgery assessed by cTnI release. The short ventilation duration in patients who underwent hypothermic CPB needs to be confirmed in a future investigation.
Authors: Sarah Baos; Karen Sheehan; Lucy Culliford; Katie Pike; Lucy Ellis; Andrew J Parry; Serban Stoica; Mohamed T Ghorbel; Massimo Caputo; Chris A Rogers Journal: JMIR Res Protoc Date: 2015-05-25