Remote Ischemic Preconditioning for Renal Protection in Patients Undergoing Transcatheter Aortic Valve Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Renal function as a measured by serum creatinine
研究概览
简要总结
Severe aortic stenosis remains a major cause of morbidity and mortality of the elderly affecting approximately 3% of elderly patients with an increasing number of patients undergoing transcatheter aortic valve interventions. As part of pre-procedural planning these patients undergo CT scans and receive contrast during the procedure. These patients often have baseline renal insufficiency and are high risk of contrast induced nephropathy despite pre-hydration techniques. The purpose of this study is to evaluate the efficacy of this simple and safe procedure in preventing renal injury in this particular population.
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
- 否
入选标准
- •Adults aged 18 or older presenting with moderate to severe aortic stenosis for a trans-catheter aortic valve intervention
排除标准
- •Patients in cardiogenic shock defined as requiring circulatory or hemodynamic support with a device, vasopressors or inotropes
- •Systemic hypotension (systolic blood pressure < 90mmHg)
- •Patients currently on hemodialysis
- •Presence of an arteriovenous dialysis fistula or graft or lymphedema in either arm
- •Patients enrolled in other active cardiovascular investigational studies
- •Severe comorbidities with a life expectancy of less than 6 months
- •Pregnant or lactating women
- •Patients unable to provide consent
- •Patients taking the medication glibenclamide for treatment of diabetes
结局指标
主要结局
Renal function as a measured by serum creatinine
时间窗: 48-72 hours
Assess the effects on post procedure renal injury. Lab work will be obtained in the form of a basic metabolic panel evaluating the creatinine level. A baseline basic metabolic panel will be obtained prior to scheduled procedure to evaluate baseline renal function and then 48-72 hours post procedure, the optimal time to see the effects of contrast induced nephropathy to evaluate the degree of acute kidney injury. The baseline and post procedure measurements of renal function will be compared between both arms of the study.
次要结局
- Clinical Outcomes(6 months)
研究者
Brittany Fuller, MD
Co-Investigator
Henry Ford Health System