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

University of Leicester1 site in 1 country116 target enrollmentMay 7, 2019

ConditionsCardiac Valve Disease Coronary Artery Disease Organ Failure, Multiple

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cardiac Valve Disease
Sponsor: University of Leicester
Enrollment: 116
Locations: 1
Primary Endpoint: Change of Serum Troponin I level
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 7, 2019

End Date

October 7, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Leicester

Responsible Party

Sponsor

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.
•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

Outcomes

Primary Outcomes

Change of Serum Troponin I level

Time Frame: Baseline, 0-6, 6-12, 24, 48 and 72 hours post-operatively

Measurement of Serum Troponin level and expressed as ng/L.

Change of Serum Creatinine level

Time Frame: Baseline, 0-6, 6-12, 24, 48, 72, and up to 96 hours post-operatively

Measurement of Serum Creatinine level and expressed as umol/L.

Secondary Outcomes

Post-surgery organ injury: GI Tract injury (Biomarker) - Bilirubin(Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.)
Post-surgery organ injury: Sepsis-related Organ Failure(Baseline, pre-operatively, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively)
Post-surgery organ injury: Kidney Injury (Urinary Biomarkers) - NGAL (Neutrophil gelatinase associated lipocalcin)(Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively)
Post-surgery organ injury: GI Tract injury (Biomarker) - Serum Amylase(Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.)
Clinical events: Stroke(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Rate of mortality(Within 30-days from surgery and at 1 year from surgery)
Bleeding and Transfusion(Blood loss at 6 hours post-operatively)
Mechanism study: Chromatin Immunoprecipitation (ChIP) of microvessels from tissue biopsies(At time of surgery)
Mechanism study: Mitochondrial function measured in right atrium myocardium tissue biopsies(At time of surgery)
Post-surgery organ injury: Lung Injury using the Berlin ARDS Score(Baseline, immediately pre-surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively)
Post-surgery organ injury: GI Tract injury (Biomarker) - Alkaline Phosphatase(Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.)
Assessment of resource use: Intensive Care Unit(Time (hours) measured from the start of surgery to discharge from ICU (up to 30 days))
Assessment of resource use: Hospital Stay(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Acute Liver Injury - ALT (Alanine Transaminase)(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Acute Liver Injury - Serum Amylase(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Mechanism study: Mitochondrial function of microvessels from tissue biopsies(At time of surgery)
Mechanism study: microRNA isolation of microvessels from tissue biopsies(At time of surgery)
Mechanism study: Chromatin Immunoprecipitation (ChIP) in right atrium myocardium tissue biopsies(At time of surgery)
Mechanism study: Chromatin Immunoprecipitation (ChIP) in adipose tissue biopsies(At time of surgery)
Post-surgery organ injury: GI Tract injury (Biomarker) - ALT (Alanine Transaminase)(Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.)
Clinical events: Low cardiac output(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Mechanism study: Measurement of microRNA in urine samples(Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.)
Post-surgery organ injury: Kidney Injury (Urinary Biomarkers) - microRNA (Neutrophil gelatinase associated lipocalcin)(Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively)
Post-surgery organ injury: Kidney Injury(At 6 weeks and then 3 months post-surgery)
Post-surgery organ injury: GI Tract injury (Biomarker) - AST (Aspartate Transaminase)(Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.)
Clinical events: Sepsis(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Peak lactate(Within 24 hours of surgery)
Clinical events: Acute Liver Injury - Bilirubin(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Mechanism study: microRNA isolation in right atrium myocardium tissue biopsies(At time of surgery)
Assessment of resource use: Extubation(Time (hours) measured from the start of surgery to extubation (up to 30 days))
Clinical events: Acute Lung Injury(Baseline, immediately pre-surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively)
Clinical events: Acute Liver Injury - AST (Aspartate Transaminase)(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Acute Liver Injury - Alkaline Phosphatase(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: Acute Intestinal Injury(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Clinical events: A composite endpoint Organ Injury, Mortality and Sepsis(Time (days) measured from the start of surgery to discharge from hospital (up to 90 days))
Mechanism study: microRNA isolation in adipose tissue biopsies(At time of surgery)
Mechanism study: Measurement of histone acetylation in urine samples(Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.)
Mechanism study: Mitochondrial function measured in adipose tissue biopsies(At time of surgery)
Mechanism study: Measurement of microvesicles in urine samples(Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.)
Mechanism study: Measurement of gene expression in urine samples(Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.)