Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: A protocol for a randomised controlled study (ProMPT2)

Abstract

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. Trial Registration ISRCTN15255199. Registered in March 2019.

Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial

“…Following on from the publication of the trial protocol [ 4 ], here we prospectively detail the statistical analysis plan to evaluate the ProMPT-2 trial, in advance of any outcome data analysis. This will help to reduce the risk of reporting bias and data-driven analyses.…”

“…The study population is adults undergoing first time, urgent or elective CABG surgery at a specialist UK cardiac surgery centre. Full details of the study background and design have been reported elsewhere [ 4 ]. This analysis plan was written and finalised during the 12-month follow-up period for the trial and in advance of any analysis of trial outcomes to minimise reporting bias.…”

Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a Statistical Analysis Plan for the ProMPT-2 randomised controlled trial.

“…The study population is adults undergoing rst time, urgent or elective CABG surgery at a specialist UK cardiac surgery centre. Full details of the study background and design have been reported elsewhere (4). This analysis plan was written and nalised during the 12-month follow-up period for the trial and in advance of any analysis of trial outcomes to minimise reporting bias.…”