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

NCT05740397 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2023-02-23

No results posted yet for this study

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.

Conditions

  • Heart; Surgery, Heart, Functional Disturbance as Result

Interventions

OTHER

Management of mean arterial pressure during cardiopulmonary by-pass in cardiac surgery interventions. The MAP will be mantained in the range of values of each study arm

The patients enrolled to elective cardiac surgeries will be evaluated during a pre-operative outpatient visit and widely informed about the chance to participate in the study. When patients undergo to the elective surgery general anaesthesia is administered and CPB is installed. The nominal flow for each patient will be 2,4 l/min/m2. To keep the MAP values around those corresponding to the randomized group, vasodilator (if MAP overcomes the assigned MAP value) or vasoconstrictor drugs will be used (if MAP value is lower than the assigned group). The following drugs will be used: nitroglicerine at incremental dose of 0,01 mcg/kg/min for a vasodilator effect and norepinephrine at incremental dose of 0,01 mcg/kg/min for a vasoconstrictor effect

Sponsors & Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2023-12-31
Completion
2026-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05740397 on ClinicalTrials.gov