NCT04015973招募中不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Change of Serum Troponin I level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Exclusion criteria for optional MRI research procedure:
- •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
结局指标
主要结局
Change of Serum Troponin I level
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
研究点 (2)
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