Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy.
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- contrast induced nephropathy
研究概览
简要总结
Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy.
The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.
The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study.
Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure.
All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany).
All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.
详细描述
Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography. It has been demonstrated that following contrast media application the renal outer medullar blood flow is reduced, resulting in medullar ischemia. N-acetylcysteine (NAC) together with well hydration stands in the center of treatments to prevent contrast induced nephropaathy (CIN).
Since, hypoxia plays a major role in the pathogenesis of CIN it seems rational that further increase oxygen delivery to the renal tissue will further ameliorate the expected CIN.
The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography.
The study protocol was approved by the local Ethics Committee and each patient will give written informed consent before including in the study. The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study.
Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure.
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, Investigator, Outcomes Assessor)
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
- •elective coronary angiography
- •estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2
- •inform consent
排除标准
- •acute renal failure
- •acute myocardial infarction
- •noncompensated congestive heart failure
- •hemodynamic instability
- •known sensitivity to contrast media
- •patients who had been exposed to contrast media during the last 3 months
- •Patients with oxygen blood saturation of less than 94% at room air.
研究组 & 干预措施
100% oxigen
patients will recive 100% oxigen in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
干预措施: 100% oxigen (Drug)
placebo
patients will recive 21% oxigen (room air) in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
干预措施: placebo (Drug)
结局指标
主要结局
contrast induced nephropathy
时间窗: 48 hours
次要结局
- Nitric Oxide in urine sample(day -1, and 6,24,48 hours after exposure)
- cystatin-C(day -1, and 6,24,48 hours after exposure)
- urinary isoprostanes(day -1, and 6,24,48 hours after exposure)
- blood urea and creatinin(day -1, and 6,24,48 hours after exposure)
研究者
Fany Tusia
medical center
Assaf-Harofeh Medical Center