Comparing methods for managing blood pressure during heart surgery

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

This study is testing different ways to manage blood pressure during heart surgery to see which method helps patients recover better and avoid complications.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona (other)
• Locations: 1 site (Verona)
• Trial ID: NCT05740397 on ClinicalTrials.gov

What this trial studies

This trial aims to evaluate different strategies for managing Mean Arterial Pressure (MAP) during cardiopulmonary bypass (CPB) in cardiac surgery. It will be the first multicenter, randomized, controlled study to compare three distinct MAP management approaches to determine the most effective strategy for maintaining organ perfusion and preventing postoperative complications. The study will include patients undergoing elective heart surgeries with specific eligibility criteria, ensuring a controlled environment for assessing outcomes. By analyzing the effects of varying MAP levels, the trial seeks to establish updated guidelines for CPB management based on contemporary practices and technologies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 undergoing elective cardiac surgeries with a low surgical risk and preserved heart function.

Not a fit: Patients who may not benefit from this study include those requiring emergency surgeries, reoperations, or those with high surgical risk scores.

Why it matters

Potential benefit: If successful, this study could lead to improved patient outcomes by optimizing blood pressure management during heart surgeries, potentially reducing complications and enhancing recovery.

How similar studies have performed: While few single-center studies have explored MAP management during CPB, this multicenter approach is novel and aims to resolve existing contradictions in previous findings.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Verona

• Azienda Ospedaliera Universitaria Integrata di Verona — Verona, Italy (RECRUITING)

Study contacts

• Study coordinator: Alessandra Francica

Conditions: Heart, Surgery, Heart, Functional Disturbance as Result, Cardiopulmonary by-pass