跳至主要内容
临床试验/NCT02908009
NCT02908009招募中不适用

An Observational Case Control Study to Identify the Role of Epigenetic Regulation of Genes Responsible for Energy Metabolism and Mitochondrial Function in the Obesity Paradox in Cardiac Surgery

University of Leicester1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Post surgery inotrope score

研究概览

简要总结

This is a prospective, single-centre case control comparison of expression of target genes responsible for energy utilisation, mitochondrial function and oxidative stress and levels of histone acetylation/ DNA methylation in obese and non-obese adult cardiac surgery patients. The study aims to test several inter-related hypotheses in a consecutive sequence of patients undergoing coronary artery bypass grafting.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with pre-existing paroxysmal, persistent or chronic atrial fibrillation,

排除标准

  • Patients with pre-existing inflammatory state: sepsis undergoing treatment, acute kidney injury within 5 days, chronic inflammatory disease, congestive heart failure.
  • Emergency or salvage procedure.
  • Ejection fraction <30 %.
  • Patient in a critical preoperative state (Kidney Disease: Improving Global Outcomes (KDIGO) Stage 3 AKI [20] or requiring inotropes, ventilation or intra-aortic balloon pump).
  • Pregnancy.

结局指标

主要结局

Post surgery inotrope score

时间窗: inotrope score measured up to 48 hours post-surgery

inotrope score measured up to 48 hours post-surgery

次要结局

  • Changes in expression of target genes(Collected at the time of surgery)
  • Changes in epigenetic regulation of target genes from left atrial biopsies.(Collected at the time of surgery)
  • Data to calculate Multiple Organ Dysfunction (MOD) score.(baseline, and up to 96 hours post surgery)
  • Changes in mitochondrial function(before and after sugery (up to 12 hours post surgery))
  • Myocardial Injury(baseline and 24 hours)
  • Acute kidney injury(baseline, and up to 15 days post surgery (discharge))
  • Perioperative medications.(Collected pre op)
  • Perioperative clinical characteristics(Collected pre op)
  • Data to capture Acute Respiratory Distress Syndrome (Berlin criteria ARDS).(baseline, and up to 96 hours post surgery)
  • Data on demographics(Pre Op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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