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.
| Original language | English |
|---|---|
| Journal | Perfusion |
| Early online date | 16 Feb 2023 |
| DOIs | |
| Publication status | E-pub ahead of print - 16 Feb 2023 |
Bibliographical note
Funding Information:The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This project (EME Project: 15/180/55) is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.
Funding Information:
The ProMPT2 study is sponsored by University of Bristol. The sponsor is responsible for the oversight of the ProMPT2 study and will ensure the study is managed appropriately. The study was designed and is delivered in collaboration with the Bristol Trials Centre, a UKCRC registered clinical trials unit, which is in receipt of National Institute for Health Research (NIHR) CTU support funding. The research team acknowledges the support of the British Heart Foundation, NIHR Clinical Research Network and the NIHR Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. The authors would like to thank all research and clinical teams involved in the recruitment, coordination and data entry for this study. Particular thanks are given to Wendy Underwood, Kim Wright, Lei Zhang, Samir Bellani and Liz McCullagh for their support in the set-up of the study.
Publisher Copyright:
© The Author(s) 2023.