Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass
Mean Arterial Pressure (MAP) Trial: Study Protocol for a Multicenter, Randomized, Controlled Trial to Compare Three Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass
Azienda Ospedaliera Universitaria Integrata Verona
900 participants
May 3, 2021
INTERVENTIONAL
Conditions
Summary
* 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.
Eligibility
Inclusion Criteria7
- 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
- Preserved or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) at preoperative echocardiography
- Patients with an estimated Glomerular filtration rate (eGFR) ≥ 40 ml/min/mq calculated using the Modification of Diet in Renal Disease formula (MDRD)
- Signed informed consent
Exclusion Criteria12
- Age < 18 years and >80 years
- Reoperation
- Emergent, urgent and salvage procedures
- Euroscore II > 9%
- Right toracothomy procedures
- Any surgical procedure not listed above (i.e. tricuspid valve surgery, aortic root surgery, congenital heart diseases, surgery necessitating hypotermic circulation arrest, surgical ablation of atrial fibrillation etc.)
- More than mild left ventricular dysfunction at preoperative echocardiogram (LVEF < 40%)
- Patients with critical preoperative state: any ventricular fibrillation or ventricular tachycardia, preoperative cardiac massage, preoperative ventilation before anaesthetic room, preoperative inotropes or mechanical circulatory support planned before cardiac intervention (i.e. during coronary angiography) and other conditions according to Euroscore II definition.
- Patients with an estimated eGFR < 40 ml/min/mq calculated using the MDRD or patients on dialysis.
- Patients with chronic obstructive pulmonary disease > 3 stage according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019 classification.
- Patients with severe preoperative epatic failure (CHILD-PUGH ≥ B)
- Patient with severe symptomatic carotid atheromasia
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Interventions
The 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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05740397