The PRE-OP ENERGY Trial

NCT ID: NCT04015973

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-07
• Study Completion Date: 2024-10-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A: Control

Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B: High energy diet

High energy diet for 8-12 weeks pre-surgery

Group Type: EXPERIMENTAL

High energy diet

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gavin J Murphy, MD

Role: STUDY_CHAIR

BHF Professor of Cardiac Surgery, University of Leicester

Mustafa Zakkar, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, University of Leicester

Locations

University of Leicester

Leicester, Leicestershire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Mustafa Zakkar, PhD

Role: CONTACT

mz207@le.ac.uk

0116258 ext. 3019

Hardeep Aujla

Role: CONTACT

ha200@le.ac.uk

0116250 ext. 2650

Other Identifiers

246009

Identifier Type: REGISTRY

Identifier Source: secondary_id

18/EM/0254

Identifier Type: OTHER

Identifier Source: secondary_id

0668

Identifier Type: -

Identifier Source: org_study_id