An interventional study of High energy diet in Cardiac Valve Disease, Coronary Artery Disease and Organ Failure, Multiple, sponsored by University of Leicester. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by University of Leicester · Not applicable, Interventional, and Treatment
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.
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:
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's planned enrollment of 116 is above the median of 100 across 311 interventional studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →University of Leicester is the lead sponsor of 170 studies on the registry; 51 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ALL of the following:
Exclusion Criteria:
Any of the following:
Exclusion criteria for optional MRI research procedure:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard Care
High energy diet for 8-12 weeks pre-surgery
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.
Change of Serum Creatinine level
Measurement of Serum Creatinine level and expressed as umol/L.
Time frame: Baseline, 0-6, 6-12, 24, 48, 72, and up to 96 hours post-operatively
Change of Serum Troponin I level
Measurement of Serum Troponin level and expressed as ng/L.
Time frame: Baseline, 0-6, 6-12, 24, 48 and 72 hours post-operatively
Post-surgery organ injury: Sepsis-related Organ Failure
Sepsis-related Organ Failure Assessment (SOFA) Score. Range 0-3, 3 being the worse score
Time frame: 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)
Urine samples will be analysed for biomarkers of renal injury. Measurement of NGAL level will be expressed as μg/L.
Time frame: Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively
Post-surgery organ injury: Kidney Injury (Urinary Biomarkers) - microRNA (Neutrophil gelatinase associated lipocalcin)
Urine samples will be analysed for biomarkers of renal injury. Measurement of microRNA in urine samples will be represented by the frequency (%) of identified microRNA.
Time frame: Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively
Post-surgery organ injury: Kidney Injury
Absolute change from baseline for serum creatinine
Time frame: Daily for 5 days from Baseline
Post-surgery organ injury: Kidney Injury
Serum creatinine and eGFR in all patients using the Modification of Diet in Renal Disease equation. The following is the IDMS-traceable MDRD Study equation (for creatinine methods calibrated to an IDMS reference method) GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) The equation does not require weight or height variables because the results are reported normalized to 1.73 m2 body surface area, which is an accepted average adult surface area.
Time frame: At 6 weeks and then 3 months post-surgery
Post-surgery organ injury: Lung Injury using the Berlin ARDS Score
Using the Berlin ARDS score, the measurement of Arterial Alveolar oxygen ratio expressed in kPa/L.
Time frame: Baseline, immediately pre-surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively
Post-surgery organ injury: GI Tract injury (Biomarker) - AST (Aspartate Transaminase)
Measurement of AST levels in serum and expressed in IU/L. Acute liver injury will be defined as an acute derangement of three times the upper limit of normal.
Time frame: Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.
Post-surgery organ injury: GI Tract injury (Biomarker) - ALT (Alanine Transaminase)
Measurement of ALT levels in serum and expressed in IU/L. Acute liver injury will be defined as an acute derangement of three times the upper limit of normal.
Time frame: Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.
Post-surgery organ injury: GI Tract injury (Biomarker) - Bilirubin
Measurement of Bilirubin levels in serum and expressed in μmol/L. Acute liver injury will be defined as an acute derangement of three times the upper limit of normal.
Time frame: Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.
Post-surgery organ injury: GI Tract injury (Biomarker) - Alkaline Phosphatase
Measurement of Alkaline Phosphatase levels in serum and expressed in IU/L. Acute liver injury will be defined as an acute derangement of three times the upper limit of normal.
Time frame: Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.
Post-surgery organ injury: GI Tract injury (Biomarker) - Serum Amylase
Measurement of Amylase levels in serum and expressed in IU/L. Acute pancreatitis will be defined as a serum amylase concentration \>1000 ng/ml.
Time frame: Baseline, pre-assessment, pre-operatively, 0-6 and at 6-12, 24, 48, 72 and 96 hours post-operatively.
Assessment of resource use: Extubation
Time until extubation
Time frame: Time (hours) measured from the start of surgery to extubation (up to 30 days)
Assessment of resource use: Intensive Care Unit
Length of stay in Intensive Care Unit. Number of hours between admission and discharge from the High Dependency Unit (HDU)
Time frame: Time (hours) measured from the start of surgery to discharge from ICU (up to 30 days)
Assessment of resource use: Hospital Stay
Length of stay in hospital. Number of days between admission and discharge from the hospital
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Sepsis
Sepsis will be defined as suspected or documented infection and an acute change in total SOFA score ≥2 points consequent to the infection. For the purposes of the trial suspected or documented infection will be defined as the commencement of intravenous antibiotics. The rise in SOFA score will be assessed within 72 hours of the commencement of antibiotics. Range of SOFA is 0 to 3, 3 being the worse. For the purposes of the study suspected or documented infection will be defined as the commencement of intravenous antibiotics. The rise in SOFA score will be assessed within 72 hours of the commencement of antibiotics.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Peak lactate
Peak lactate within 24 hours of surgery and time to resolution of hyperlactataemia (arterial serum lactate \>2.5 mmol/L) post peak.
Time frame: Within 24 hours of surgery
Clinical events: Acute Lung Injury
Measurement of PaO2/FiO2 ratio and expressed in kPa/L.
Time frame: Baseline, immediately pre-surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively
Clinical events: Low cardiac output
Low cardiac output, defined as new intra-or postoperative intra-aortic balloon pump insertion or a cardiac index of \<2.2 L/min/ m2 refractory to appropriate intravascular volume expansion after correction or attempted correction of any dysrhythmias, or the administration of the inotropes Dobutamine, Enoximone, Milrinone or Levosimendan.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Stroke
Stroke; diagnosed by brain imaging (CT or MRI), in association with new onset focal or generalized neurological deficit (defined as deficit in motor, sensory or co-ordination functions)
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - AST (Aspartate Transaminase)
Acute liver injury will be defined as an acute derangement of liver enzymes three times the upper limit of normal, or a serum amylase concentration \>1000 ng/m.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - ALT (Alanine Transaminase)
Acute liver injury will be defined as an acute derangement of liver enzymes three times the upper limit of normal, or a serum amylase concentration \>1000 ng/m.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - Bilirubin
Acute liver injury will be defined as an acute derangement of liver enzymes three times the upper limit of normal, or a serum amylase concentration \>1000 ng/m.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - Alkaline Phosphatase
Acute liver injury will be defined as an acute derangement of liver enzymes three times the upper limit of normal, or a serum amylase concentration \>1000 ng/m.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - Serum Amylase
Acute liver injury will be defined as an acute derangement of liver enzymes three times the upper limit of normal, or a serum amylase concentration \>1000 ng/m.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Intestinal Injury
Acute intestinal injury will be defined a radiological, operative or post-mortem evidence of gut ischaemia.
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Rate of mortality
Rate of mortality at 30-days and 1 year from the date of surgery
Time frame: Within 30-days from surgery and at 1 year from surgery
Clinical events: A composite endpoint Organ Injury, Mortality and Sepsis
As above for description of organ injury, mortality and sepsis
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Bleeding and Transfusion
The total number of units of red cells and other blood components transfused during the operative period and post-operative hospital stay will be recorded
Time frame: Blood loss at 6 hours post-operatively
Mechanism study: Mitochondrial function of microvessels from tissue biopsies
50-100 mg biopsies obtained from pedicled left internal mammary artery biopsies. The mitochondrial function will be measured through the Bioenergetic Health Index. The Bioenergetic Health Index (BHI) is calculated using the following formula: BHI=(ATP-linked×reserve capacity)/(proton leak×non-mitochondrial) - as described by Chacko et al. The expected range is 0-100.
Time frame: At time of surgery
Mechanism study: microRNA isolation of microvessels from tissue biopsies
The findings will be represented by the frequency (%) of identified microRNA. 50-100 mg biopsies obtained from pedicled left internal mammary artery biopsies.
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) of microvessels from tissue biopsies
To identify protein binding sites that may help identify functional elements in the genome. Findings will be represented by the number (n) of binding sites. 50-100 mg biopsies obtained from pedicled left internal mammary artery biopsies.
Time frame: At time of surgery
Mechanism study: Mitochondrial function measured in right atrium myocardium tissue biopsies
50-100 mg myocardial biopsies will be obtained from the right atrium at surgery. The mitochondrial function will be measured through the Bioenergetic Health Index. The Bioenergetic Health Index (BHI) is calculated using the following formula: BHI=(ATP-linked×reserve capacity)/(proton leak×non-mitochondrial) - as described by Chacko et al. The expected range is 0-100.
Time frame: At time of surgery
Mechanism study: microRNA isolation in right atrium myocardium tissue biopsies
50-100 mg myocardial biopsies will be obtained from the right atrium at surgery. The findings will be represented by the frequency (%) of identified microRNA.
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) in right atrium myocardium tissue biopsies
50-100 mg myocardial biopsies will be obtained from the right atrium at surgery. To identify protein binding sites that may help identify functional elements in the genome. Findings will be represented by the number (n) of binding sites.
Time frame: At time of surgery
Mechanism study: Mitochondrial function measured in adipose tissue biopsies
Adipose tissue collected from epicardial fat at time of surgery. The mitochondrial function will be measured through the Bioenergetic Health Index. The Bioenergetic Health Index (BHI) is calculated using the following formula: BHI=(ATP-linked×reserve capacity)/(proton leak×non-mitochondrial) - as described by Chacko et al. The expected range is 0-100.
Time frame: At time of surgery
Mechanism study: microRNA isolation in adipose tissue biopsies
Adipose tissue collected from epicardial fat at time of surgery. The findings will be represented by the frequency (%) of identified microRNA.
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) in adipose tissue biopsies
Adipose tissue collected from epicardial fat at time of surgery. To identify protein binding sites that may help identify functional elements in the genome. Findings will be represented by the number (n) of binding sites.
Time frame: At time of surgery
Mechanism study: Measurement of microvesicles in urine samples
Identification of microvesicles. The findings will be represented by the frequency (%) of each identified microvesicle.
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Mechanism study: Measurement of microRNA in urine samples
The findings will be represented by the frequency (%) of identified microRNA.
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Mechanism study: Measurement of histone acetylation in urine samples
The findings will be reported as acetylated H3 (ug/mg) over time (hours)
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Mechanism study: Measurement of gene expression in urine samples
Whole genome sequencing will be achieved through ATAC sequencing. The identified genes will be characterised by average expression count over ATAC.
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Body Composition: Bone Density Scan (DEXA)
Assessments of muscle mass/sarcopenia (Appendicular lean mass taken from the DEXA scan)
Time frame: Baseline, pre-assessment and 3 months post-surgery
Imaging Assessment of Cardiometabolic Status: Trans-Oesophageal Echo
Diastolic and systolic left ventricular function will be evaluated using intra-operative trans-oesophageal echo in all patients, as per standard care.
Time frame: At time of surgery
Imaging Assessment (optional): Cardiac Magnetic Resonance Imaging - Cardiac Function
Assessment of cardiac function, by assessing ventricular function. This will be expressed as ejection fraction (%). Intravenous contrast will be administered via an indwelling venous catheter.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Imaging Assessment (optional): Cardiac Magnetic Resonance Imaging - Cardiac adiposity content
Assessment of cardiac adiposity content. A percentage of adipose tissue over total body mass will be calculated. Intravenous contrast will be administered via an indwelling venous catheter.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Imaging Assessment (optional): Cardiac Magnetic Resonance Imaging - Visceral adiposity content
Assessment of visceral adiposity content. A percentage of adipose tissue over total body mass will be calculated. Intravenous contrast will be administered via an indwelling venous catheter.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Fitness, Frailty and Muscle Strength: Six Minute Walk Test
Fitness will be assessed using the 6-minute walk test (6MWT) which is a standardized test that provides a valid assessment of functional performance. It provides a global assessment of exercise capacity and may better reflect daily activity than more traditional laboratory tests.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Fitness, Frailty and Muscle Strength: Hand Grip Test
Hand grip strength will be measured quantitatively by using a dynamometer. The result provides an objective index of general upper body strength and combined with appendicular lean mass (taken from the DEXA scan) could be used to define sarcopenia.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Fitness, Frailty and Muscle Strength: PRISMA-7 Questionnaire
Frailty assessment will be by use of the PRISMA-7 Questionnaire. The questions asked are: 1. Are you older than 85 years? 2. Are you male? 3. In general, do you have any health problems that require you to limit your activities? 4. Do you need someone to help you on a regular basis? 5. In general, do you have any health problems that require you to stay at home? 6. If you need help, can you count on someone close to you? 7. Do you regularly use a stick, walker or wheelchair to move about? The participant is asked to answer Yes or No to all 7 questions. SCORING: If the respondent had 3 or more "yes" answers, this indicates an increased risk of frailty and the need for further clinical review.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Activity Levels and Sleep: Accelerometer Assessments
Activity levels and sleep are measured by the use of seven day accelerometer assessments
Time frame: Baseline, pre-assessment and 3 months post-surgery
Comorbidity and Inflammation - CRP (C-Reactive-Protein) assay (Abcam)
Pre-existing inflammation, renal impairment and heart failure will be assessed using highly sensitive CRP assay, NT-proBNP (both Abcam), and estimated Glomerular Filtration Rate (from serum creatinine). The acceptable range for CRP values using the abcam kit is 34.29 - 25,000 pg/mL. For values above 25ng/mL, the samples will be diluted and re-assayed. Samples \< 34.29 pg/mL will be re-assayed at higher concentration when possible; otherwise the concentrations will be accepted if higher than assay detection limit (2 pg/L). For samples \<2pg/mL a no-expression value will be assigned.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Comorbidity and Inflammation - NT-proBNP (Abcam)
Pre-existing inflammation, renal impairment and heart failure will be assessed using highly sensitive CRP assay, NT-proBNP (both Abcam), and estimated Glomerular Filtration Rate (from serum creatinine). The acceptable range for NT-proBNP values using the abcam kit is 0.14 - 100 ng/mL. For values above 100ng/mL, the samples will be diluted and re-assayed. Samples \< 0.14 ng/mL will be re-assayed at higher concentration when possible; otherwise a no-expression value will be assigned.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Comorbidity and Inflammation - estimated Glomerular Filtration Rate
Pre-existing inflammation, renal impairment and heart failure will be assessed using highly sensitive CRP assay, NT-proBNP (both Abcam), and estimated Glomerular Filtration Rate (from serum creatinine). Formula for GFR (mL/min/1.73 m2) = 175 × (Scr)-1.154 × (Age)-0.203 × (0.742 if female) × (1.212 if African American) The equation does not require weight or height variables because the results are reported normalized to 1.73 m2 body surface area, which is an accepted average adult surface area.
Time frame: Baseline, pre-assessment and 3 months post-surgery
Endothelial function: Blood samples
Markers of endothelial activation will be measured in blood samples using flow cytometry.
Time frame: Baseline, 6-12 and 48 hours post-surgery
Endothelial function: Reactive Hyperaemia Peripheral Arterial Tonometry (RH-PAT)
Regional endothelial dysfunction will be measured as the reactive hyperaemia peripheral arterial tonometry (RH-PAT) index using the Endo-PAT 2000 (Itamar Medical Ltd., Caesarea, Israel)
Time frame: 1 day before surgery and 24 hours post-surgery
Endothelial function: Global endothelial dysfunction
Global endothelial dysfunction will also be measured indirectly as the measured time to resolution of oxygen debt defined as the period of time from the end of surgery until the measured serum arterial lactate level falls below 2.5 mmol/L.
Time frame: End of surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively (until the timepoint serum arterial lactate falls below 2.5 mmol/L)
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