Mean Arterial Pressure (MAP) Trial: study protocol for a multicentre, randomized, controlled trial to compare three different strategies of mean arterial pressure management during cardiopulmonary bypass

TL;DR

This study compares three strategies for managing blood pressure during heart surgery to find the best way to ensure proper organ perfusion.

Contribution

It is the first multicentre, randomized, controlled trial comparing three MAP management strategies during cardiopulmonary bypass.

Findings

The trial will assess serum lactate levels as an indicator of tissue hypoxia during surgery.

It will evaluate intraoperative tissue oxygenation and postoperative complications related to organ perfusion.

The study aims to determine the optimal MAP strategy for end-organ perfusion during cardiac surgery.

Abstract

One of the main goals of cardiopulmonary bypass (CPB) is targeting an adequate mean arterial pressure (MAP) during heart surgery, in order to maintain appropriate perfusion pressures in all end-organs. 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 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 is the first multicentre, randomized, controlled study which compares three different strategies of MAP management during the CPB.

We described herein the methodology of a multicentre, randomized, controlled trial comparing three different approaches to MAP management 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 tissue oxygenation and major postoperative complications related to organ malperfusion.

This trial will assess the best strategy to target the MAP during CPB, thus further improving the outcomes of cardiac surgery.

NCT05740397 (retrospectively registered; 22/02/2023)

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