Evaluation of Remote Preconditioning on Heart Resistance to Ischemia and Reperfusion Injury
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Molecular pathway activation
研究概览
简要总结
Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years
- •Scheduled for coronary artery bypass grafting with or without valve replacement associated
- •Use of blood cardioplegia
- •EuroSCORE II greater than or equal to 1.0%
排除标准
- •History of cardiogenic shock
- •Complications in the admission
- •Pregnant patients
- •Severe peripheral arterial disease affecting the upper limbs
- •Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
- •Significant pulmonary disease (˂ FEV1 40%)
- •Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
- •Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)
研究组 & 干预措施
IRPC, Remote preconditioning
This group will be submitted to ischemic preconditioning
干预措施: IRPC, Remote preconditioning (Procedure)
Control
This patients will be submitted to the standard surgery protocol in the institution. The patients will not be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion.
结局指标
主要结局
Molecular pathway activation
时间窗: 2 days
Inflammatory response
时间窗: 10 days
次要结局
- All cause of mortality(180 days)
研究者
Orlando Petrucci
Phd
University of Campinas, Brazil