Cardiopulmonary Protection of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Troponin I serum release over 24 hours after surgery
研究概览
简要总结
During cardiac surgery with cardiopulmonary bypass , injury occurs to the heart muscle and the lung.The heart and lung injury is a serious complication ,which increases both mortality and morbidity of cardiac surgery .Remote ischemic preconditioning(RIPC) with transient upper limb ischemia/reperfusion is a novel, simple, cost-free,non-pharmacological and non-invasive strategy.Recent some trials suggested that RIPC could provide myocardial protection by reducing serum cardiac biomarkers,however, more recent multicenter studies[9-11] had failed to show the protective effects of RIPC with respect to the troponin release and lung injury.
Remote ischemic preconditioning (RIPC) is reported to have the early-phase and delayed-phase organ protective effects, whether the modified RIPC protocol induced repeatedly has the cardiopulmonary protective effect is still uncertain.
详细描述
modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC.The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
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 (Investigator)
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 undergoing heart surgery on cardiopulmonary bypass
- •Patients aged 18 years to 80 years
排除标准
- •Inability to give informed consent
- •Cardiogenic shock
- •Cardiac arrest on current admission
- •Left ventricular ejection fraction less than 30%
- •Current atrial fibrillation
- •Preoperative use of inotropics or mechanical assist device
- •Patients with significant hepatic dysfunction (Prothrombin>2.0 ratio)
- •Patients with known renal failure with a GFR<30 mL/min/1.73 m2
- •Patients with significant pulmonary disease (FEV1<40% predicted)
- •Recent myocardial infarction (within 7 days)
- •Recent systemic infection or sepsis (within 7 days)
- •Severe stroke (within 2 months)
- •Significant peripheral arterial disease affecting the upper limbs
- •Previous serious psychiatric disorders (e.g. schizophrenia, dementia)
- •Surgeries: cardiac transplantation, concomitant carotid endarterectomy , previous heart surgery,off-pump surgery, emergency surgery
研究组 & 干预措施
Modified Remote Ischemic Preconditioning(mRIPC)
modified RIPC was induced at 24 h, 12 h and 1 h before surgery to reinforce the protective effects of RIPC. The single RIPC protocol was induced by three cycles of upper-limb ischemia, a standard blood-pressure cuff was placed on the ringt upper arm, then inflated the cuff to 200 mm Hg for 5 minutes, followed by 5 min of cuff deflation.
干预措施: Modified Remote Ischemic Preconditioning (Procedure)
Control
Control group without remote ischemic preconditioning
干预措施: Control (Procedure)
结局指标
主要结局
Troponin I serum release over 24 hours after surgery
时间窗: 24 hours post surgery
次要结局
- salveolar-arterial oxygen gradient over 24 hours after surgery(24 hours post surgery)
- PaO2/FiO2 ratio over 24 hours after surgery(24 hours post surgery)
- Inotrope score(12 hours post surgery)
研究者
Su Liu
M.D/Ph.D
Xuzhou Medical University