Cardiac Valve DiseaseNCT04015973
The PRE-OP ENERGY Trial
A study testing High energy diet in people with Cardiac Valve Disease and Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Valve Disease, Coronary Artery Disease, Organ Failure, Multiple
- What is being tested?
- High energy diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2019to 7 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leicester
Leicester, Leicestershire, LE3 9QP
About this study
Official title: 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
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.
Read the 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:
- 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'.
- The effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction.
- The trial intervention will not result in long-term adverse changes in cardiometabolic status.
- Metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis.
- 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.
- Metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.
- Being tested
- High energy diet
- Medical subject headings
- Heart Valve Diseases, Coronary Artery Disease, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High energy dietDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Control | No intervention | Standard Care |
| Group B: High energy diet | Experimental | High energy diet for 8-12 weeks pre-surgery Receives: Dietary Supplement: High energy diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Serum Creatinine level
Measurement of Serum Creatinine level and expressed as umol/L.
Measured: 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.
Measured: Baseline, 0-6, 6-12, 24, 48 and 72 hours post-operatively
Secondary outcomes (41)
Post-surgery organ injury: Sepsis-related Organ Failure
Sepsis-related Organ Failure Assessment (SOFA) Score. Range 0-3, 3 being the worse score
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: Within 24 hours of surgery
Clinical events: Acute Lung Injury
Measurement of PaO2/FiO2 ratio and expressed in kPa/L.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start7 May 2019
- Primary completionApr 2024 (estimated)
- Study completion7 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gavin J Murphy, MD, Study chair, BHF Professor of Cardiac Surgery, University of LeicesterMustafa Zakkar, PhD, Principal investigator, Associate Professor, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015973
- Sponsor's protocol ID
- 0668
- Other IDs
- 246009, 18/EM/0254
- Status last verified
- Nov 2023
- First submitted
- 20 May 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04015973
- Acronym / sponsor ID
- 0668
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- 7 Oct 2024 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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'.
- The effects of the trial intervention will not be attributable to changes in frailty, activity or baseline organ dysfunction.
- The trial intervention will not result in long-term adverse changes in cardiometabolic status.
- Metabolic preconditioning will confer protection against post-cardiac surgery kidney injury by increasing the expression of genes that promote renal tubular homeostasis.
- 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.
- Metabolic preconditioning will confer protection against post-cardiac surgery endothelial dysfunction by increasing the expression of genes that promote endothelial homeostasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Control | No intervention | –Standard Care |
| Group B: High energy diet | Experimental | Dietary Supplement: High energy dietHigh energy diet for 8-12 weeks pre-surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High energy dietAn 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. | Dietary supplement | Group B: High energy diet |
Primary outcome
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.
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.
41 secondary outcomes
Post-surgery organ injury: Sepsis-related Organ Failure
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)
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)
Time frame: Baseline, 1 day pre-op, 6-12, 24 and 48 hours post-operatively
Post-surgery organ injury: Kidney Injury
Time frame: Daily for 5 days from Baseline
Post-surgery organ injury: Kidney Injury
Time frame: At 6 weeks and then 3 months post-surgery
Post-surgery organ injury: Lung Injury using the Berlin ARDS Score
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)
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)
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
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
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
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 frame: Time (hours) measured from the start of surgery to extubation (up to 30 days)
Assessment of resource use: Intensive Care Unit
Time frame: Time (hours) measured from the start of surgery to discharge from ICU (up to 30 days)
Assessment of resource use: Hospital Stay
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Sepsis
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Peak lactate
Time frame: Within 24 hours of surgery
Clinical events: Acute Lung Injury
Time frame: Baseline, immediately pre-surgery, 0-6, 6-12, 24, 48, 72 and 96 hours post-operatively
Clinical events: Low cardiac output
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Stroke
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)
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)
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Liver Injury - Bilirubin
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
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
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Acute Intestinal Injury
Time frame: Time (days) measured from the start of surgery to discharge from hospital (up to 90 days)
Clinical events: Rate of mortality
Time frame: Within 30-days from surgery and at 1 year from surgery
Clinical events: A composite endpoint 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
Time frame: Blood loss at 6 hours post-operatively
Mechanism study: Mitochondrial function of microvessels from tissue biopsies
Time frame: At time of surgery
Mechanism study: microRNA isolation of microvessels from tissue biopsies
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) of microvessels from tissue biopsies
Time frame: At time of surgery
Mechanism study: Mitochondrial function measured in right atrium myocardium tissue biopsies
Time frame: At time of surgery
Mechanism study: microRNA isolation in right atrium myocardium tissue biopsies
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) in right atrium myocardium tissue biopsies
Time frame: At time of surgery
Mechanism study: Mitochondrial function measured in adipose tissue biopsies
Time frame: At time of surgery
Mechanism study: microRNA isolation in adipose tissue biopsies
Time frame: At time of surgery
Mechanism study: Chromatin Immunoprecipitation (ChIP) in adipose tissue biopsies
Time frame: At time of surgery
Mechanism study: Measurement of microvesicles in urine samples
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Mechanism study: Measurement of microRNA in urine samples
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Mechanism study: Measurement of histone acetylation in urine samples
Time frame: Baseline,1 day before surgery, 6-12, 24 and 48 hours post-operatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin J Murphy, MD study chair
BHF Professor of Cardiac Surgery, University of Leicester
Mustafa Zakkar, PhD principal investigator
Associate Professor, University of Leicester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High energy diet in people with Cardiac Valve Disease and Coronary Artery Disease, run by University of Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Zakkar, PhD (0116258 ext. 3019, mz207@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Serum Creatinine level (time frame: Baseline, 0-6, 6-12, 24, 48, 72, and up to 96 hours post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.