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

NCT05740397 | Recruiting DMC

• 1 other identifier: "MAP" PROG.3048CESC
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiopulmonary by-pass

Outcome Measures

Primary Outcomes (1)

• Serum lactate peak (Lmax) (mmol/l) detected during Cardiopulmonary by-pass time

  The mean of this value will be compared in the three groups of treatment.

  at the beginning of CPB, every 20 minutes during CPB, at the end of CPB, at the end of surgery

Secondary Outcomes (12)

• The area under the curve (AUC) of the serum lactate values measured during CPB

  at the beginning of CPB, every 20 minutes during CPB, at the end of CPB, at the end of surgery

• Number of cases with serum lactate peak > 3 mmol/l during CPB

  at the beginning of CPB, every 20 minutes during CPB, at the end of CPB, at the end of surgery

• Evaluation of intraoperative cerebral perfusion (through monitoring of NIRS)

  at anesthesia induction, before skin incision, at the beginning of CPB, every 20 minutes (until minute 300), at the end of CPB and at the end of surgery.

• Intraoperative pulmonary perfusion (through Pa/Fi ratio, paO2, paCO2 at ABG and VO2R and DO2 of CDI)

  at the beginning of CPB, every 20 minutes (until minute 300) and at the end of CPB.

• Evaluation of intraoperative and postoperative low cardiac output syndrome (through the calculation of VISmax)

  at the beginning of CPB, every 20 minutes (until minute 300) and at the end of CPB.

Study Arms (3)

Standard MAP

OTHER

Control group: MAP values between 50-60 mmHg

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

High MAP

OTHER

First Comparator group: MAP values between 70-80 mmHg

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

Patient-tailored MAP

OTHER

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

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

Interventions

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 OTHER

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

High MAP; Patient-tailored MAP; Standard MAP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, 37126, Italy

RECRUITING

Related Publications (28)

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  PMID: 38491507 DERIVED

Central Study Contacts

Alessandra Francica

CONTACT

3356213738; alessandrafrancica@yahoo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The present study is a randomized controlled three parallel groups trial. The patient allocation is 1:1:1. The outcome of patients undergoing cardiac surgery and treated with a MAP standard during CPB is compared to patients treated with high MAP and patient-tailored MAP during CPB

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: May 3, 2021
• Primary Completion: December 31, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)