ProMPT-2
Research type
Research Study
Full title
Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: Propofol cardioplegia for myocardial protection randomised controlled trial: the PROMPT2 Study
IRAS ID
234266
Contact name
Gianni Angelini
Contact email
Sponsor organisation
University of Bristol
Eudract number
2018-000169-35
Duration of Study in the UK
years, 45 months, days
Research summary
Almost 2.3 million people in the UK are living heart disease and >36,000 cardiac surgery operations are carried out each year. During surgery the heart is isolated from the rest of the circulation and a heart-lung machine is used to supply oxygen to the blood and pump it around the body. The heart is stopped and provided with nutrients by a cardioplegic solution that is injected directly into the heart arteries. This allows the surgeon to operate on the heart while it is still and not filled with blood, but looking after the heart in this way during surgery is not ideal. The heart muscle can become short of oxygen, and when the heart is restarted, and blood starts to flow again the muscle can be harmed.
The damage is believed to be caused mainly by the formation of highly reactive molecules known as ‘free radicals’ in the heart muscle during the time it is short of oxygen. Propofol is a general anaesthetic widely used in cardiac surgery and research suggests that propofol could protect the heart muscle against damage from free radicals. We want to investigate whether adding propofol to the cardioplegic solution in patients having isolated coronary artery bypass grafting (CABG) surgery using the heart-lung machine is beneficial and if the benefit is greater the more propofol that is used.
We propose to conduct a study, known as a randomised controlled trial (RCT), in which patients undergoing CABG surgery are allocated by chance to a ‘high’ dose of propofol, a ‘low’ dose of propofol or no additional propofol. Every other aspect of care will stay the same. We will monitor all study patients to check that adding propofol to the cardioplegic solution is safe and an independent group of experts will review these data regularly. At the end of the study we will compare information about patients who received the different doses of propofol with information about patients who received no additional propofol to determine whether propofol is beneficial. We will do this by studying chemicals released by the heart and other organs in the body when they are damaged or stressed. We will measure these chemicals in blood samples taken before and after the operation. We will also collect information on post-operative complications at 3 and 12 months and will collect data from patients on their quality of life (QoL) at 3 and 12 months.
If we find that adding propofol to the cardioplegic solution reduces organ damage, patients undergoing cardiac surgery may have a faster recovery and fewer major complications in the year following surgery. This should also lead to reduced costs for the NHS.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0472
Date of REC Opinion
21 Sep 2018
REC opinion
Favourable Opinion