Effect of Intravenous Iron Repletion on Renal Function in Patients With Iron Deficiency and Acute Kidney Injury, Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Renal function estimated in GFR at 3 months of randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine.
研究概览
简要总结
This clinical trial aims to carry out research on the effect on hemoglobin and renal function of intravenous administration of iron dextran as a repletion strategy in patients with iron deficiency anemia and acute kidney injury, in which the patient may benefit from this drug as it is expected to correct anemia, ferropenia and renal function parameters, when compared with a control group (placebo), the safety of the drug will also be assessed by recording adverse effects.
The investigators will point out with the patient the risks and benefits of their inclusion in this type of study and the investigators will attend to all the doubts that are generated, as well as immediately report to the research ethics committee any serious adverse effects. The results will be presented at national and international conferences and will be published in high-impact journals, and will also be the subject of a thesis to achieve the title of specialist.
详细描述
Acute kidney injury is a complication that occurs in up to 30% of hospitalized patients, iron deficiency has a high incidence in the critically ill patient population and has been associated with multiple complications such as the development of anemia and renal dysfunction. The presence of iron deficiency, anemia and acute kidney damage is a common combination in critically ill patients and it has been seen that iron deficiency promotes mitochondrial dysfunction and this can be improved with the correction of intravenous iron, as has happened in clinical trials of patients with acute heart failure, improving their clinical evolution.
There is insufficient evidence for the implementation of intravenous iron with the aim of improving the parameters of iron deficiency anaemia in patients with acute kidney injury.
To the knowledge of the investigators, there is no clinical trial that has explored this outcomes.
Primary objective:
• Renal function estimated in GFR at 3 months after randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients with acute kidney injury
- •iron levels <13 μmol/L or a transferrin saturation <20%
排除标准
- •AKI within the past three months
- •less than 18 years old
- •Chronic Kidney Disease grade 5
- •chronic dialysis
- •kidney transplant
- •hospital stay less tahn 48 hours
- •received any red blood cell transfusion before randomization
- •missing data that would render analysis incomplete.
研究组 & 干预措施
Iron dextran IV
In patients with acute renal damage, they will be aleatorized to receive the administration of intravenous iron dextran 1200mg in 1 single exhibition compared to placebo.
干预措施: Iron dextran (Drug)
Placebo
In patients with acute renal damage, they will be aleatorized to receive the administration of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Renal function estimated in GFR at 3 months of randomization. Which will be evaluated by the estimation of the GFR by the equation CKD-EPI by serum creatinine.
时间窗: 3 months of randomization
The CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) equation was developed in an effort to create a more precise formula to estimate glomerular filtrate rate (GFR) from serum creatinine and other readily available clinical parameters, especially at when actual GFR is \>60 mL/min per 1.73m2.
次要结局
- All of the following will be at hospital discharge and 28 days after hospital discharge between the intervention group (iron replacement) compared to the control group (placebo).(28 days of discharge from hospital between iron dextran group and placebo group)
- Need of renal replacement therapy(28 days of discharge from hospital between iron dextran group and placebo group)
研究者
Jonathan Samuel Chavez Iñiguez
Head of nephrology Jonathan Samuel Chavez Iñiguez MD.
Hospital Civil de Guadalajara