Acquired Methemoglobinemia Observational Registry
- Registration Number
- NCT03542760
- Lead Sponsor
- Hospital Quality Foundation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
- Treatment of methemoglobinemia with another methylene blue product
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Secondary Treated Group Methylene Blue Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms Primary Treated Group Methylene Blue 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%.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
Time to Normalization of Blood Pressure Index Hospitalization Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.
Trial Locations
- Locations (32)
UT Southwestern
🇺🇸Dallas, Texas, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
University of Kansas Health System
🇺🇸Kansas City, Kansas, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Bridgeport Hospital
🇺🇸Bridgeport, Connecticut, United States
St John Medical Center
🇺🇸Detroit, Michigan, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
University of Tennessee Health Science Center
🇺🇸Memphis, Tennessee, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Oregon Health & Sciences University
🇺🇸Portland, Oregon, United States
UC Davis Health
🇺🇸Sacramento, California, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
HealthPartners Regions
🇺🇸Saint Paul, Minnesota, United States
Partners Healthcare; Brigham and Women's
🇺🇸Boston, Massachusetts, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
IU Health
🇺🇸Indianapolis, Indiana, United States
Tampa General
🇺🇸Tampa, Florida, United States
Palmetto General
🇺🇸Palm Beach Gardens, Florida, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Holy Name Medical Center
🇺🇸Teaneck, New Jersey, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
New York Methodist
🇺🇸New York, New York, United States
Mercy Health
🇺🇸Youngstown, Ohio, United States
Einstein Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
University Hospitals
🇺🇸Cleveland, Ohio, United States
Houston Methodist
🇺🇸Houston, Texas, United States