The PRE-OP ENERGY Trial

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    116
  • sponsor
    University of Leicester
Updated on 12 February 2022
bypass graft
heart surgery
cardiopulmonary bypass

Summary

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:

  1. 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'.
  2. The effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction.
  3. The trial intervention will not result in long-term adverse changes in cardiometabolic status.
  4. Metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis.
  5. 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.
  6. Metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.

Details
Condition Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple
Treatment High energy diet
Clinical Study IdentifierNCT04015973
SponsorUniversity of Leicester
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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