Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- incidence of contrast-induced nephropathy (CIN)
研究概览
简要总结
The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.
详细描述
Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN.
Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments.
In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 over 18 yr
- •estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m2
排除标准
- •Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
- •Pregnancy or lactation
- •Use of contrast agent within 1 week
- •Emergent CAG or PCI
- •Not recovered from AKI(acute kidney injury)
- •Use of nephrotoxic drugs within 48 hr
- •Cardiogenic shock (SBP(systolic blood pressure) < 90 mmHg) or pulmonary edema
- •Uncontrolled hypertension (SBP ≥ 200 mmHg or DBP(diastolic blood pressure) ≥ 130 mmHg)
- •History of hypersensitivity to contrast agent
- •Known allergy or hypersensitivity to EPO(erythropoietin)
- •Use of EPO within 1 month
- •Anemia (hemoglobin < 9 g/dL)
- •Ventilatory care
研究组 & 干预措施
darbepoetin-α
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
干预措施: darbepoetin-α (Drug)
isotonic saline
Infusion of isotonic saline will be performed 1 hour before angiography
干预措施: isotonic saline (Drug)
结局指标
主要结局
incidence of contrast-induced nephropathy (CIN)
时间窗: 48 hours
a greater than 25 percent increase in serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using the contrast agent
次要结局
- maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)(1 month after the intervention)
研究者
Ki Young Na
Associate Professor
Seoul National University Bundang Hospital