Methemoglobinemia, Methemoglobinemia, Acquired
Conditions
Keywords
Methylene Blue
Brief summary
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.
Interventions
DRUGMethylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
Sponsors
Prove pharm
Hospital Quality Foundation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Inclusion criteria
* 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
Exclusion criteria
* Refusal of consent (in those subjects approached for consent where required by local institutional procedures) * Treatment of methemoglobinemia with another methylene blue product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Methemoglobin 1h after Administration of ProvayBlue | 1h post-treatment | Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Normalization of Respiratory Rate | Index Hospitalization | Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia. |
| Time to Normalization of Heart Rate | Index Hospitalization | Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia. |
| Time to Normalization of Blood Pressure | Index Hospitalization | Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia. |
| Prevalence and Nature of Adverse Events | Within 10 days of Treatment | Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prevalence by Agent | Index Hospitalization | Prevalence of acquired methemoglobinemia cases by suspected causal agent |
| Resolution of Symptoms | Index Hospitalization | Resolution of methemoglobinemia-related symptoms during the index hospitalization |
Countries
United States
Outcome results
None listed