Acquired Methemoglobinemia Observational Registry

Hospital Quality Foundation24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Methemoglobinemia, Acquired Methemoglobinemia

Interventions

Methylene Blue

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (32)

Cedars Sinai

Los Angeles, California, United States

UC Davis Health

Sacramento, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

Hartford Hospital

Hartford, Connecticut, United States

Palmetto General

Palm Beach Gardens, Florida, United States

Tampa General

Outcomes

Primary Outcomes

Reduction of Methemoglobin 1h after Administration of ProvayBlue

Level of methemoglobin 1h after administration of ProvayBlue for treatment of acquired methemoglobinemia compared to pre-treatment level of methemoglobin.

Time frame: 1h post-treatment

Secondary Outcomes

Time to Normalization of Respiratory Rate

Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

Time frame: Index Hospitalization

Time to Normalization of Heart Rate

Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

Time frame: Index Hospitalization

Time to Normalization of Blood Pressure

Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.

Time frame: Index Hospitalization

Prevalence and Nature of Adverse Events

Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue

Time frame: Within 10 days of Treatment