Overview
The PRE-OP ENERGY Trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.
Description
PRE-OP ENERGY is a single centre, unblinded, parallel group, randomised controlled trial of a pre-operative high energy diet, versus a control group receiving standard care.
The trial will test a number of specific hypotheses:
- A pre-surgery high energy diet will protect against post-cardiac surgery organ failure by altering the pre-surgery cardiometabolic state, a process referred to as 'metabolic preconditioning'.
- The effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction.
- The trial intervention will not result in long-term adverse changes in cardiometabolic status.
- Metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis.
- Metabolic preconditioning will confer protection against post-cardiac surgery myocardial injury by increasing the expression of genes that promote myocardial mitochondrial homeostasis via effects on chromatin histone deacetylation.
- Metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.
Eligibility
Inclusion Criteria:
ALL of the following:
- Adult cardiac surgery patients (≥18 years) undergoing cardiac surgery (CABG, Valve, or CABG and Valve) with cardiopulmonary bypass.
- BMI<30
- Able, in the opinion of the investigator, and willing to give informed consent.
- Do not have diagnosed coeliac disease
- Able to understand English
Exclusion Criteria:
Any of the following:
- Urgent, emergency or salvage procedure
- Patients with end stage renal failure defined as an estimated Glomerular Filtration rate (eGFR) <15 mL/min/1.73 m2 calculated from the Modification of Diet in Renal Disease equation,1 or patients who are on long-term haemodialysis or have undergone renal transplantation.
- Patients with persistent or chronic atrial fibrillation.
- Patients with severe liver dysfunction; hepatitis, cirrhosis, jaundice.
- Women who are pregnant or who may become pregnant in the intraoperative period.
- Patients who are participating in another interventional clinical trial.
- Unable, in the opinion of the investigator, or unwilling to give informed consent.
- Have diagnosed coeliac disease
- Unable to understand English
Exclusion criteria for optional MRI research procedure:
- Permanent pacemaker or ICD
- Brain Aneurysm Clip
- Implanted neural stimulator
- Cochlear implant (specific implant must be checked that it is MR safe)
- Ocular foreign body (e.g. metal shavings) unless removed
- Other implanted medical devices: (e.g. Swan Ganz catheter)
- Insulin pump
- Retained metal shrapnel or bullet
- Claustrophobia