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Open Access 01-12-2024 | Heart Surgery | Study protocol

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

Authors: Alessandra Francica, Gina Mazzeo, Antonella Galeone, Daniele Linardi, Livio San Biagio, Giovanni Battista Luciani, Francesco Onorati

Published in: Trials | Issue 1/2024

Abstract

Background

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.

Methods

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.

Discussion

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

Trial registration

NCT05740397 (retrospectively registered; 22/02/2023)

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Title: 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
Authors: Alessandra Francica
Gina Mazzeo
Antonella Galeone
Daniele Linardi
Livio San Biagio
Giovanni Battista Luciani
Francesco Onorati
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Heart Surgery
Heart Surgery
Published in: Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-024-07992-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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