High energy diet before cardiac surgery

A Randomised Controlled Trial of a Pre-operative High Energy Diet for the Prevention of Organ Injury in Cardiac Surgery: The PRE-OP ENERGY Trial

This study is testing if eating a high energy diet before heart surgery can help protect patients' organs during the procedure.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 116 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Leicester (other)
• Locations: 1 site (Leicester, Leicestershire)
• Trial ID: NCT04015973 on ClinicalTrials.gov

What this trial studies

The PRE-OP ENERGY Trial aims to evaluate whether a high energy diet before cardiac surgery can protect patients from organ damage during the procedure. This single-center, unblinded, parallel group, randomized controlled trial will compare the effects of a high energy diet against standard care in adult patients undergoing cardiac surgery with cardiopulmonary bypass. The study will investigate various hypotheses related to metabolic preconditioning and its potential benefits on kidney, myocardial, and endothelial health post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adult cardiac surgery patients aged 18 and older with a BMI under 30, who are undergoing procedures like CABG or valve surgery.

Not a fit: Patients with end-stage renal failure, severe liver dysfunction, or those undergoing urgent procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of organ failure in patients undergoing cardiac surgery.

How similar studies have performed: While the concept of metabolic preconditioning is being explored, this specific approach with a high energy diet in cardiac surgery is relatively novel.

Eligibility criteria

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

Where this trial is running

Leicester, Leicestershire

• University of Leicester — Leicester, Leicestershire, United Kingdom (RECRUITING)

Study contacts

• Principal investigator: Mustafa Zakkar, PhD — Associate Professor, University of Leicester
• Study coordinator: Mustafa Zakkar, PhD

Conditions: Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple