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临床试验/NCT01401140
NCT01401140已完成3 期

Coronary Surgery: Comparing the Protective Effects of Two Cardioplegic Solutions: Custodiol Versus St Thomas, on Cardiac Metabolism, as Assessed Using Microdialysis

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
29
试验地点
1
主要终点
Lactate concentrations per-operatory

研究概览

简要总结

An estimated 8% to 15% of patients hospitalized for a coronary pathology undergo coronary revascularization surgery with extracorporeal circulation (ECC). (1) Like most major cardiac surgical interventions, it is performed with the heart stopped; this leads to more or less severe myocardial ischemia. The heart is stopped (and therefore deprived of oxygen) for a duration that varies depending on the number of bypasses required, and on the local difficulties encountered. On average, myocardial ischemia lasts between 20 and 80 minutes. Heart protection during coronary revascularization surgery remains a crucial factor in limiting the heart's aerobic function during aortic clamping, and in minimizing the resulting post-operatory ventricular dysfunction. Its quality is a determining factor of the post-operatory issue.

High-performance heart protection solutions such as Custodiol have been used by heart surgeons for a few years. They are used as an alternative choice to other cardioplegic solutions, the efficacy of which has already been proven (St Thomas). These two myocardial protection solutions have never been evaluated in an in vivo, randomized, comparative trial.

详细描述

Myocardial microdialysis is the state-of-the-art technique for evaluating the protective effects of cardioplegic solutions; it enables physicians to monitor oxidation-reduction muscle metabolism during an ongoing operation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Patient was referred to the Cardiovascular Surgery Unit for surgical coronary revascularization
  • Patient has anterior interventricular stenosis
  • Patient signed the informed consent form
  • Patient is covered by health insurance

排除标准

  • Patients with beating heart surgery indication (no extracorporeal circulation required)
  • Emergency surgery and patients who suffered myocardial infarction less than a week before surgery
  • Iterative surgery

研究组 & 干预措施

St Thomas

Active Comparator

干预措施: St Thomas (Drug)

Custodiol

Experimental

干预措施: Custodiol (Drug)

结局指标

主要结局

Lactate concentrations per-operatory

时间窗: Every 10 minutes between the beginning of surgery, and declamping (per-operatory)

Mean interstitial lactate concentrations (lactate peak and lactate/pyruvate ratio) observed between the beginning of surgery, and declamping in each patient group (St Thomas cardioplegia group vs Custodiol cardioplegia group)

次要结局

  • Anoxic variations 24h(Every hours after end of surgery and until the 24th hour following declamping.)
  • Drug consumption(At 72 hours after declamping)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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