Acquired Methemoglobinemia Observational Registry

Methemoglobinemia Clinical Trial

— metHb  

Official title:

Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03542760
• Other study ID #: HQF-METHB-2018001
• Status: Completed
• Start date: May 31, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: April 2023
• Source: Hospital Quality Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Methemoglobinemia
• Methemoglobinemia, Acquired

Intervention

Drug:
• Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Partners Healthcare; Brigham and Women's	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals	Cleveland	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	St John Medical Center	Detroit	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist	Houston	Texas
United States	IU Health	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	University of Kansas Health System	Kansas City	Kansas
United States	Cedars Sinai	Los Angeles	California
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	New York Methodist	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Palmetto General	Palm Beach Gardens	Florida
United States	Einstein Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health & Sciences University	Portland	Oregon
United States	UC Davis Health	Sacramento	California
United States	Washington University	Saint Louis	Missouri
United States	HealthPartners Regions	Saint Paul	Minnesota
United States	University of Washington	Seattle	Washington
United States	Tampa General	Tampa	Florida
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Mercy Health	Youngstown	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Quality Foundation	Prove pharm

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prevalence by Agent	Prevalence of acquired methemoglobinemia cases by suspected causal agent	Index Hospitalization
Other	Resolution of Symptoms	Resolution of methemoglobinemia-related symptoms during the index hospitalization	Index Hospitalization
Primary	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.	1h post-treatment
Secondary	Time to Normalization of Respiratory Rate	Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.	Index Hospitalization
Secondary	Time to Normalization of Heart Rate	Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.	Index Hospitalization
Secondary	Time to Normalization of Blood Pressure	Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.	Index Hospitalization
Secondary	Prevalence and Nature of Adverse Events	Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue	Within 10 days of Treatment