A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Carotide-femoral pulse velocity
研究概览
简要总结
The purpose of this study is to evaluate the effect of preoperative remote ischaemic preconditioning (RIPC) on organ damage and the functional characteristics of arteries in patients undergoing vascular surgery. In addition, we investigate the connection between RIPC and changes in the functional characteristics of arteries and low molecular weight metabolites.
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
- Double (Participant, Care Provider)
盲法说明
Patient, patient's physician, surgeon, anaesthesiologist and everyone else in the surgical team were blinded to study intervention. Blinding was attained with manometer's scale covered. Second arterial stiffness measurement was carried out by a study member who did not know the patient's group affiliation.
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
- •patients who are willing to give full informed consent for participation and
- •who are undergoing open abdominal aortic aneurysm repair or
- •who are undergoing endovascular aortic aneurysm repair or
- •who are undergoing lower limb revascularization surgery or
- •who are undergoing carotid endarterectomy
排除标准
- •patients under age of 18
- •patients who are pregnant
- •patients with known malignancy during last 5 years
- •patients with permanent atrial fibrillation or flutter
- •patients with symptomatic upper limb atherosclerosis
- •patients who require home oxygen therapy
- •patients with eGFR < 30 ml/min/1.73 m2, measured preoperatively
- •patients who have had myocardial infarction during last month
- •patients who have had upper limb vein thrombosis
- •patients who have undergone vascular surgery in the axillary region
- •patients who are not able to follow the study regimen
研究组 & 干预措施
Remote ischaemic preconditioning
Four episodes of 5 minutes of ischaemia are performed. Between all the episodes there is a 5-minute period of reperfusion.
干预措施: Remote ischaemic preconditioning (Procedure)
Control to RIPC
Four episodes of 5 minutes during which the pressure in the cuff is equal to venous pressure are performed. Between all the episodes there is a 5-minute pause.
干预措施: Control to RIPC (Procedure)
结局指标
主要结局
Carotide-femoral pulse velocity
时间窗: 24 h
Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery
Augmentation index
时间窗: 24 h
Measured with Sphygmocor XCEL * baseline characteristics are measured before surgery * measuring is repeated 24 h after surgery
次要结局
- Cardiac markers(24 h)
- Traditional biomarkers of renal function(24 h)
- Markers of inflammation and oxidative stress(24 h)
- Duration of hospital stay(30 days)
- Duration of intesive care unit stay(30 days)
- Cardiac event(10 days)
- Postoperative complications(10 days)
- 1- year mortality(1 year)
- Complications of remote ishcaemic preconditioning(10 days)
- Novel biomarkers of renal function(24 h)
- Estimated glomerular filtration rate(24 h)
- Low molecular-weight metabolites(24 h)
- Arterial elasticity indices(24 h)
研究者
Jaak Kals
Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD
Tartu University Hospital