Erythropoietin Role in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Transfusion
研究概览
简要总结
The use of erythropoietin to treat anemia in acute kidney injury (AKI) is controversial. No previous clinical trial has assessed the possible reduction of transfusions when erythropoietin is started very early in a setting of in-hospital acute kidney injury.
This randomised multicenter pragmatic clinical trial will compare the need for transfusion in acute kidney injury between two groups: group 1 will receive erythopoietin 4000 UI every other day and group 2 the usual treatment.
详细描述
Introduction
Background and rationale
Since the release of the recombinant human erythropoietin (rhuEPO) at the beginning of the 90s, transfusions are less needed to treat anemia in chronic kidney disease patients. This has been a major revolution in the management of renal anemia in chronic kidney disease and led to a tremendous decrease in hepatitis B and C transmissions in dialysis patients.
However the use of rHuEPO to treat anemia in acute kidney injury (AKI) is controversial. AKI is a common disease with a worldwide incidence estimated at 21% and a trend to be higher in the critical care setting.
The Kidney Disease Improving Global Outcomes (KDIGO) work group combined the RIFLE and AKIN classifications of AKI. Therefore, AKI has been defined as an increase in serum creatinine (SCr) ≥0.3 mg/dL (≥26.5 μmol/L) within 48 h or an increase in SCr to ≥1.5 times baseline within the last 7 days or a urine volume of <0.5 mL/kg/h for 6 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients > 18 years old hospitalized with acute kidney injury and anemia
排除标准
- •pregnant women, terminally ill patients, patients with major or minor thalassemia, patients with stable chronic kidney disease or patients on dialysis and patients who were receiving rHuEPO or any erythropoiesis-stimulating agent (ESA) before admission.
研究组 & 干预措施
Group 1
Recombinant human erythropoietin 4000 UI will be administered subcutaneously every other day
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Transfusion
时间窗: Admission- One month
Number of red blood cell transfusions
次要结局
- Renal survival(Admission - One month)
- Mortality(Admission - One month)
研究者
Mabel Aoun
MD, instructor, nephrology department
Saint-Joseph University