Methemoglobinemia Following Intravenous Iron Treatment Administered as Ferric Carboxymaltose or Ferric Derisomaltose in Patients With Anemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Difference in methemoglobin after ferric carboxymaltose
研究概览
简要总结
Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.
详细描述
Methemoglobin is an isoform of hemoglobin without oxygen carrying properties. Higher levels of methemoglobin may impact oxygen transport of the blood and increase the risk of tissue hypoxia. Methemoglobinemia has been reported as side effect of different drugs such as antibiotics or local anesthetics, but not after iron preparations. There is only one case report of increased levels of methemoglobin following intravenous iron therapy.
Patients with anemia due to iron deficiency can be treated with intravenous iron preparations such as ferric carboxymaltose or ferric derisomaltose. Anemia itself reduces oxygen transport of the blood, increasing the risk of tissue hypoxia due to methemoglobinemia in those patients.
This study aims to assess methemoglobinemia following treatment with intravenous iron in patients with anemia. The report will include case reports of patients with severe anemia who developed methemoglobinemia following treatment with ferric derisomaltose. Furthermore, methemoglobin levels are evaluated before and after intravenous iron administration in a cohort of adult patients with anemia who are scheduled to receive ferric carboxymaltose or ferric derisomaltose in routine care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •for patients in the cohort study:
- •prescription of administration of intravenous iron (ferric carboxymaltose or ferric derisomaltose)
- •for patients in the case report:
- •- patients with severe anemia who developed methemoglobinemia following administration of ferric derisomaltose
排除标准
- •declined consent
- •known or suspected methemoglobinemia of genetic or other origin
- •previous administration of intravenous iron within one week before study sampling.
结局指标
主要结局
Difference in methemoglobin after ferric carboxymaltose
时间窗: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric carboxymaltose.
Difference in methemoglobin after ferric derisomaltose
时间窗: 30-120 minutes after start of iron administration
Change of methemoglobin (percent) in venous blood after compared to before treatment with ferric derisomaltose.
次要结局
- Difference in methemoglobin depending on hemoglobin level before treatment(30-120 minutes after start of iron administration)
- Difference in methemoglobin depending on age(30-120 minutes after start of iron administration)
- Difference in methemoglobin depending on drug dosage(30-120 minutes after start of iron administration)
- Difference in methemoglobin depending on sex(30-120 minutes after start of iron administration)
- Difference in methemoglobin depending on blood levels of ferritin, transferrin or iron.(30-120 minutes after start of iron administration)
- Association between difference in methemoglobin and venous lactate(30-120 minutes after start of iron administration)
研究者
Claudia Seiler
Dr. Claudia Seiler, MD. Consultant anesthesiologist, department of anesthesiology and intensive care medicine Falun hospital
Dalarna County Council, Sweden