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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Integrata di Verona
RECRUITING
Verona
Contact Information
Primary
Alessandra Francica
alessandrafrancica@yahoo.it
3356213738
Time Frame
Start Date: 2021-05-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 900
Treatments
Other: Standard MAP
Control group: MAP values between 50-60 mmHg
Other: High MAP
First Comparator group: MAP values between 70-80 mmHg
Other: Patient-tailored MAP
Second Comparator group: MAP comparable to the patient's pre-operative MAP. This one will be calculated by performing 3 blood pressure measurement in three different moments of the day before surgery (at 8 am, at 3 pm, and at 9 pm), and will be calculated using the standard formula Diastolic AP + 0,33 x (systolic AP - Diastolic AP). The preoperative MAP value obtained will be target during CPB, within a range of ± 10 mmHg
Related Therapeutic Areas
Sponsors
Leads: Azienda Ospedaliera Universitaria Integrata Verona

This content was sourced from clinicaltrials.gov