Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 32
- 主要终点
- Reduction of Methemoglobin 1h after Administration of ProvayBlue
研究概览
简要总结
This prospective, observational registry aims to collect real-world data regarding the safety and efficacy of ProvayBlue® (methylene blue 0.5%) used according to normal standard of care for the treatment of acquired methemoglobinemia. Methylene blue has been used for decades as a rescue medication for the treatment of methemoglobinemia, a rare and potentially life-threatening condition in which elevated levels of methemoglobin impede the delivery of oxygen from blood to body tissues. However, consistent prospective data about the safety and efficacy of this medication are sparse, simply because of the rarity of the disorder. ProvayBlue® received accelerated FDA approval for treatment of acquired methemoglobinemia in 2016. This large, prospective, multi-center observational registry has been initiated to gain more information on the use of methylene blue in the treatment of acquired methemoglobinemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult or pediatric patients diagnosed with acquired methemoglobinemia and receiving treatment with ProvayBlue® (methylene blue 0.5%) as per the treating physician's diagnosis and the acute care facility's standard of care
- •Those acquired methemoglobinemia patients whose diagnosis is aided by measurement of methemoglobin and whose ongoing treatment is guided by re-measurement of methemoglobin ~1h post-treatment with ProvayBlue® in accordance with the US FDA Label prescribing information
排除标准
- •Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
- •Treatment of methemoglobinemia with another methylene blue product
研究组 & 干预措施
Primary Treated Group
Subjects who are administered methylene blue for treatment of acquired methemoglobinemia that is symptomatic (eg, exhibiting sleepiness, cyanosis, dizziness, etc) or with measured methemoglobin levels > 30%.
干预措施: Methylene Blue (Drug)
Secondary Treated Group
Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms
干预措施: Methylene Blue (Drug)
结局指标
主要结局
Reduction of Methemoglobin 1h after Administration of ProvayBlue
时间窗: 1h post-treatment
Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin.
次要结局
- Time to Normalization of Respiratory Rate(Index Hospitalization)
- Time to Normalization of Heart Rate(Index Hospitalization)
- Prevalence and Nature of Adverse Events(Within 10 days of Treatment)
- Time to Normalization of Blood Pressure(Index Hospitalization)