Clinical trial NCT03542760: Acquired Methemoglobinemia Observational Registry
Official title: Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Methemoglobinemia, Acquired
Methemoglobinemia
Keywords: Methylene Blue
Lead sponsor: Hospital Quality Foundation
Sponsor class: OTHER
Collaborators: name: Prove pharm
First posted: 2018-05-31
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of Methemoglobin 1h after Administration of ProvayBlue
timeFrame: 1h post-treatment
Secondary outcomes:
measure: Time to Normalization of Respiratory Rate
timeFrame: Index Hospitalization
measure: Time to Normalization of Heart Rate
timeFrame: Index Hospitalization
measure: Time to Normalization of Blood Pressure
timeFrame: Index Hospitalization
measure: Prevalence and Nature of Adverse Events
timeFrame: Within 10 days of Treatment
Other outcomes:
measure: Prevalence by Agent
timeFrame: Index Hospitalization
measure: Resolution of Symptoms
timeFrame: Index Hospitalization
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Palm Beach Gardens
country: United States
facility: Palmetto General
state: Florida
city: Tampa
country: United States
facility: Tampa General
state: Florida
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Partners Healthcare; Brigham and Women's
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: St John Medical Center
state: Michigan
city: Saint Paul
country: United States
facility: HealthPartners Regions
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: New York Methodist
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals
state: Ohio
city: Youngstown
country: United States
facility: Mercy Health
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Hospital Quality Foundation
name: Charles V Pollack, MD
role: PRINCIPAL_INVESTIGATOR
References: