Study of Remote Ischemic Preconditioning as a Preventative Method Against Subclinical Renal Injury and Contrast-induced Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup
研究概览
简要总结
Contrast-induced nephropathy (CIN) has remained significant and severe complication of angiographic procedures despite the increasing use of preventative methods. It has been associated with prolonged hospital stay, high morality and the need for dialysis. Since classically used creatinine for diagnosing of CIN does not reflect the degree of tubular injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and preventative methods are needed. Remote ischemic preconditioning is a non-invasive and safe method which in some studies has been reported to protect against contrast-induced nephropathy. The purpose of this study is to evaluate the effect of remote ischemic preconditioning (RIPC) (1) as an additional method to standard treatment to prevent subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on functional properties of arterial wall, organ damage biomarkers 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
- Triple (Participant, Care Provider, Investigator)
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
- •Age greater than 18 years, no upper age limit
- •Patients with stable coronary artery disease (II - III class according to the Canadian Cardiovascular Society) hospitalized for coronarography or with lower extremity arterial disease hospitalized for angiography
- •Written informed consent
排除标准
- •Pregnancy
- •Age less than 18 years
- •eGFR < 30 ml/min/1,73 m2
- •Simultaneous participation in an other clinical trial
- •Coexisting pathology of the upper-limbs limiting the use of the cuff (bilateral amputee, recent trauma, chronic ulcers, significant upper limb peripheral atherosclerosis (radial pulse not palpable on either side))
- •Malignant tumor (in remission less than 5 years or ongoing treatment)
- •Documented allergic reaction to iodinated contrast agent
- •Acute infection (body temperature 38 degrees Celsius or higher, c reactive protein 50mg/L or higher)
- •Cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes)
- •Documented myocardial infarction within 30 days
- •Inability to understand the instructions of the study
- •Vascular surgery in axillary region
- •Unable to lie supine for 40 minutes
- •Home oxygen treatment
- •Documented upper limb deep vein thrombosis
研究组 & 干预措施
Remote ischemic preconditioning
Remote Ischemic Preconditioning (RIPC) is performed by inflating blood pressure cuff for 5-minutes at 200 mmHg, or if patients systolic blood pressure is higher than 200 mmHg 20 mmHg above systolic pressure, alternated with 5-minute deflation for 4 times.
干预措施: Remote ischemic preconditioning (Procedure)
SHAM remote ischemic preconditioning
SHAM Remote Ischemic Preconditioning (RIPC-SHAM) is accomplished by alternating 4 cycles of 5-minute inflation with 5-minute deflation. Blood pressure cuff will be inflated to 10-20 mmHg. RIPC-SHAM is performed with standard blood pressure cuff on upper-arm.
干预措施: SHAM Remote ischemic preconditioning (Procedure)
结局指标
主要结局
Change in carotid-femoral pulse wave velocity compared with baseline and SHAM subgroup
时间窗: 24 hours
Carotid-femoral pulse wave velocity baseline measurement is performed. Second measuring is performed 24 hours after angiographic procedure. Change from baseline will be compared between RIPC and SHAM subgroups. Measuring is performed with SphygmoCor XCEL PWA and PWV Device.
Change in augmentation indices (augmentation index and heart rate-corrected augmentation index (AIx@75)) compared with baseline and SHAM subgroup
时间窗: 24 hours
Augmentation indices baseline measurement is performed. Second measuring is performed 24 hours after angiographic procedure. Change from baseline will be compared between RIPC and SHAM subgroups. Measuring is performed with SphygmoCor XCEL PWA and PWV Device.
次要结局
- Estimated glomerular filtration rate(24 hours)
- Adverse events of angiographic procedures(7 days)
- Adverse events of remote ischemic preconditioning(10 days)
- Cardiac markers(24 hours)
- Markers of oxidative stress and inflammation(24 hours)
- Traditional biomarkers of renal function(24 hours)
- Novel biomarkers of renal function(24 hours)
- Length of hospital stay(30 days)
- Cardiac event(30 days)
- Low molecular weight metabolites(24 hours)
- All-cause and cardiovascular mortality(1 year)
- Adverse events associated with femoral artery puncture(24 hours)
- Arterial elasticity indices(24 hours)
研究者
Jaak Kals
Tartu University Hospital, Clinic of Surgery, Department of Vascular Surgery, cardiovascular surgeon; MD-PhD
Tartu University Hospital