* Background: One of the main goals of the Cardiopulmonary By-Pass (CPB) is targeting an adequate Mean Arterial Pressure (MAP), in order to maintain appropriate perfusion pressures in all end-organs during heart surgery. As inheritance of early studies, a value of 50-60 mmHg has been historically accepted as the "gold standard" MAP. However, in the last decades, the CPB management has remarkably changed, thanks to the evolution of technology and the availability of new biomaterials. Therefore, as already highlighted by the latest European Guidelines, the current management of CPB can no longer refer to those pioneering studies. To date, only few single-centre studies have compared different strategies of MAP management during CPB, but with contradictory findings and without achieving a real consensus. Therefore, what should be the ideal strategy of MAP management during CPB is still on debate. This trial will be the first multicentre, randomized, controlled study to compare three different strategies of MAP management during the CPB. * Methods: We described herein the methodology of a multicenter, randomized, controlled trial comparing three different approaches to MAP targeting during CPB in patients undergoing elective cardiac surgery: the historically accepted "standard MAP" (50-60 mmHg), the "high MAP" (70-80 mmHg) and the "patient-tailored MAP" (comparable to the patient's preoperative MAP). It is the aim of the study to find the most suitable management in order to obtain the most adequate perfusion of end-organs during cardiac surgery. For this purpose, the primary endpoint will be the peak of serum lactate (Lmax) released during CPB, as index of tissue hypoxia. The secondary outcomes will include all the intraoperative parameters of tissues oxygenation and major post-operative complications related to organ malperfusion. * Discussion: This trial will assess the best strategy to target the MAP during CPB to further improve the outcomes of cardiac surgery.
Elective surgery
Index of surgical risk Euroscore II < 9%
The following procedures will be considered: Isolated or combined with aortic or mitral valve surgery coronary artery bypass graft surgery for acute or chronic coronary artery disease isolated aortic valve replacement for aortic stenosis and/or aortic regurgitation ; isolated mitral valve repair or replacement for mitral stenosis and/or mitral regurgitation; isolated ascending aorta surgery with or without aortic valve replacement
Surgical approach through complete and/or mini-sternotomy
Age < 18 years and >80 years
Reoperation
Emergent, urgent and salvage procedures
Euroscore II > 9%
Parallel
Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm
Other interventionThe patients enrolled to elective cardiac surgeries will be evaluated during a pre-operative outpatient visit and widely informed about the chance to participate in the study. When patients undergo to the elective surgery general anaesthesia is administered and CPB is installed. The nominal flow for each patient will be 2,4 l/min/m2. To keep the MAP values around those corresponding to the randomized group, vasodilator (if MAP overcomes the assigned MAP value) or vasoconstrictor drugs will be used (if MAP value is lower than the assigned group). The following drugs will be used: nitroglicerine at incremental dose of 0,01 mcg/kg/min for a vasodilator effect and norepinephrine at incremental dose of 0,01 mcg/kg/min for a vasoconstrictor effect
Serum lactate peak (Lmax) (mmol/l) detected during Cardiopulmonary by-pass time
The mean of this value will be compared in the three groups of treatment.
The area under the curve (AUC) of the serum lactate values measured during CPB
The area under the curve (AUC) of the serum lactate values measured during CPB
Number of cases with serum lactate peak > 3 mmol/l during CPB
Number of cases with serum lactate peak \> 3 mmol/l during CPB
Evaluation of intraoperative cerebral perfusion (through monitoring of NIRS)
Near-Infrared Spectroscopy NIRS (23) defined as non-invasive measurement of cerebral microcirculatory blood flow
Intraoperative pulmonary perfusion (through Pa/Fi ratio, paO2, paCO2 at ABG and VO2R and DO2 of CDI)
CDI ® 550 Blood parameter monitoring system (Terumo Europe) (22), data collection related to Oxygen Delivery (DO2), Oxygen consumption (VO2) e Oxygen extraction (O2ER), at the beginning of CPB, every 20 minutes (until minute 300) and at the end of CPB
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