Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT05740397

Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass

Led by Azienda Ospedaliera Universitaria Integrata Verona · Updated on 2023-02-23

900

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

* 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.

CONDITIONS

Official Title

Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Elective surgery
  • Surgical risk Euroscore II less than 9%
  • Procedures include isolated or combined aortic or mitral valve surgery, coronary artery bypass graft surgery, isolated aortic valve replacement, isolated mitral valve repair or replacement, 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
  • Estimated Glomerular Filtration Rate (eGFR) ≥ 40 ml/min/m2 by MDRD formula
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Age under 18 years or over 80 years
  • Reoperation
  • Emergent, urgent, or salvage procedures
  • Euroscore II greater than 9%
  • Right thoracotomy procedures
  • Surgical procedures not listed in inclusion, such as tricuspid valve surgery, aortic root surgery, congenital heart disease surgery, surgery requiring hypothermic circulatory arrest, surgical ablation of atrial fibrillation
  • More than mild left ventricular dysfunction (LVEF < 40%)
  • Critical preoperative state including ventricular fibrillation or tachycardia, preoperative cardiac massage, ventilation before anesthesia room, preoperative inotropes or mechanical circulatory support
  • Estimated eGFR less than 40 ml/min/m2 or dialysis
  • Chronic obstructive pulmonary disease stage greater than 3 (GOLD 2019 classification)
  • Severe preoperative liver failure (Child-Pugh B or higher)
  • Severe symptomatic carotid atheromatosis

AI-Screening

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Trial Site Locations

Total: 1 location

1

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy, 37126

Actively Recruiting

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Research Team

A

Alessandra Francica

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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