Journal
PERFUSION-UK
Volume -, Issue -, Pages -Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/02676591231157269
Keywords
cardiac surgery; cardiopulmonary bypass; cardioplegia; ischemia; reperfusion; propofol; randomised controlled trial
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The ProMPT2 study aims to determine whether increasing the dose of propofol, a vasodilator, can enhance cardiac protection in cardiac surgery. The study will randomize patients into three groups receiving high-dose propofol, low-dose propofol, or placebo. The primary outcome is myocardial injury assessed up to 48 hours post-surgery, with secondary outcomes including biomarkers of renal function and metabolism.
Introduction Cardiac surgery with cardiopulmonary bypass and cardioplegic arrest is known to be responsible for ischaemia and reperfusion organ injury. In a previous study, ProMPT, in patients undergoing coronary artery bypass or aortic valve surgery we demonstrated improved cardiac protection when supplementing the cardioplegia solution with propofol (6 mcg/ml). The aim of the ProMPT2 study is to determine whether higher levels of propofol added to the cardioplegia could result in increased cardiac protection. Methods and Analysis The ProMPT2 study is a multi-centre, parallel, three-group, randomised controlled trial in adults undergoing non-emergency isolated coronary artery bypass graft surgery with cardiopulmonary bypass. A total of 240 patients will be randomised in a 1:1:1 ratio to receive either cardioplegia supplementation with high dose of propofol (12 mcg/ml), low dose of propofol (6 mcg/ml) or placebo (saline). The primary outcome is myocardial injury, assessed by serial measurements of myocardial troponin T up to 48 hours after surgery. Secondary outcomes include biomarkers of renal function (creatinine) and metabolism (lactate). Ethics and Dissemination The trial received research ethics approval from South Central - Berkshire B Research Ethics Committee and Medicines and Healthcare products Regulatory Agency in September 2018. Any findings will be shared though peer-reviewed publications and presented at international and national meetings. Participants will be informed of results through patient organisations and newsletters.
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