A Randomized Double-Blind Safety Comparison of Intravenous Iron Dextran Versus Iron Sucrose in an Adult Non-Hemodialysis Outpatient Population: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of severe adverse drug reactions (ADRs)
研究概览
简要总结
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.
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
- Double (Participant, Care Provider)
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 18 to 100
- •To be receiving intravenous iron
排除标准
- •Age < 18
- •Hemodialysis
- •Previous exposure to intravenous iron
- •Unable to provide written consent
研究组 & 干预措施
Iron Dextran
干预措施: Iron dextran (Drug)
Iron Sucrose
干预措施: Iron sucrose (Drug)
结局指标
主要结局
Incidence of severe adverse drug reactions (ADRs)
时间窗: Immediate - during infusion
次要结局
- Incidence of combined mild and moderate ADRs(Immediate - during infusion)
- Incidence of delayed ADRs(delayed - within 24hrs post infusion)
- Incidence of all-cause mortality(Immediate and delayed - within 24hrs post infusion)
- Physician and nursing time required to manage ADRs(Immediate and delayed - within 24hrs post infusion)
- Response in laboratory parameters(Within 1 month)
- Cost effectiveness(Completion of study)
- Incidence of serious adverse drug reactions (ADRs)(Immediate and delayed - within 24hrs post infusion)
- Incidence of anaphylactic/anaphylactoid ADRs(Immediate - during infusion)