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Multicenter Study
. 2024 May;39(4):722-732.
doi: 10.1177/02676591231157269. Epub 2023 Feb 16.

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)

Rachael Heys  1 , Gianni D Angelini  2 , Katherine Joyce  1 , Helena Smartt  1 , Lucy Culliford  1 , Rachel Maishman  1 , Samantha E de Jesus  1 , Costanza Emanueli  3 , M-Saadeh Suleiman  2 , Prakash Punjabi  3 , Chris A Rogers  1 , Ben Gibbison  4
Affiliations
Multicenter Study

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)

Rachael Heys et al. Perfusion. 2024 May.

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.

Keywords: cardiac surgery; cardioplegia; cardiopulmonary bypass; ischemia; propofol; randomised controlled trial; reperfusion.

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Conflict of interest statement

Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: CE declares; grants or contracts from British Heart Foundation chair, programme grant and PhD scholarship, Rosetrees Trust, MEDIRAD & Covirna (EU grants); participation on a Data Safety Monitoring Board or advisory board for Diabetes UK and Scientific Research Advisory Group (SRAG).

Figures

Figure 1
Figure 1. Study schema.
Figure 2
Figure 2. Propofol supplementation of cardioplegia.
A roller pump will draw oxygenated blood. Both the cardioplegia solution and intervention will be added downstream of the blood oxygenator. Cardioplegia solution will be delivered into the blood stream via a 60 mL syringe driver (left). An additional syringe driver (right) will be used to deliver the intervention (propofol or saline) into the blood stream.
Figure 3
Figure 3. Example CUSUM chart.
The first four participants randomised did not experience a safety event, the fifth participant did experience a safety event, so the cumulative sum increased to 1, the following 5 participants randomised did not experience a safety event. The lower dotted line represents an alert and the upper an alarm.
See this image and copyright information in PMC

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