Periodic Versus Continuous (at Every Session of Hemodialysis) iv Iron Supplementation in Chronic HD Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change of serum hemoglobin level (g/dl)
研究概览
简要总结
The purpose of this study was to compare the efficacy of two regimens of intravenous iron sucrose [continuous (in every hemodialysis session) versus intermittent (every 1-4 weeks)] on the response of rHuEPO in the maintenance phase of its administration in hemodialysis patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Constant rHu-EPO and iron dose for at least 2 months before starting the study
- •Hemoglobin ≥ 8,5g/dl and <12,5 g/dl
- •Ferritin < 1000 mg/dl
- •TSAT < 50%
- •CRP < 5 mg/dl
排除标准
- •Malignant tumor disease
- •Oral iron supplementation
- •Active bleeding issues
- •Surgical intervention within the last 8 weeks before study inclusion
研究组 & 干预措施
intermittent iv administration of iron sucrose
Patients on this arm will continue to receive the same previous intermittent mode of iron sucrose.
干预措施: Iron Sucrose Supplement (Drug)
continuous iv administration of iron sucrose
Prior to the study, all our patients were receiving intravenous iron sucrose in an intermittent mode (every 1-4 weeks).Patients on this arm will receive the same previous dose of iron glucose but in a continuous mode (smaller doses of iron sucrose in every session).
干预措施: Iron Sucrose Supplement (Drug)
结局指标
主要结局
Change of serum hemoglobin level (g/dl)
时间窗: Month 0, 1, 2, 3, 4
次要结局
未报告次要终点
研究者
Efstathios Mitsopoulos
Director of Nephrology Dept
Papageorgiou General Hospital