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Compares treatment options for Heart; Surgery, Heart, Functional Disturbance as Result
Official title Trial to Compare Different Strategies of Mean Arterial Pressure Management During Cardiopulmonary By-pass
ClinicalTrials.gov ID: NCT05740397
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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...
- Surgical approach through complete and/or mini-sternotomy
- Preserved or mildly reduced left ventricular ejection fraction (LVEF ≥ 40%) at preoperative echocardiography
You likely can't join if
- Age \ 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...
See the full eligibility 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...
- 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
- Age \ 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Verona, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.