NCT04015973

The PRE-OP ENERGY Trial

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: University of Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cardiac Valve Disease
• Coronary Artery Disease
• Organ Failure, Multiple

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	High energy diet	An overfeeding regime of 135% required energy intake per day, set from baseline energy requirements consisting of high (saturated) fat snacks, added to the usual diet, supervised by a dietitian.

Timeline

• Start date: 2019-05-07
• Primary completion: 2024-04-01
• Completion: 2024-10-07
• First posted: 2019-07-11
• Last updated: 2023-11-07

Locations

1 site across 1 country: United Kingdom