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Acquired Methemoglobinemia Observational Registry (metHb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03542760
Recruitment Status : Unknown
Verified June 2018 by Hospital Quality Foundation.
Recruitment status was:  Recruiting
First Posted : May 31, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
Prove pharm
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Methemoglobinemia, Acquired Methemoglobinemia Drug: Methylene Blue

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 10 Days
Official Title: Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Primary Treated Group
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%.
Drug: Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care

Secondary Treated Group
Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms
Drug: Methylene Blue
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care




Primary Outcome Measures :
  1. Reduction of Methemoglobin 1h after Administration of ProvayBlue [ Time Frame: 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 :
  1. Time to Normalization of Respiratory Rate [ Time Frame: Index Hospitalization ]
    Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  2. Time to Normalization of Heart Rate [ Time Frame: Index Hospitalization ]
    Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  3. Time to Normalization of Blood Pressure [ Time Frame: Index Hospitalization ]
    Time to normalization of blood pressue after administration of ProvayBlue for treatment of acquired methemoglobinemia.

  4. Prevalence and Nature of Adverse Events [ Time Frame: Within 10 days of Treatment ]
    Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue


Other Outcome Measures:
  1. Prevalence by Agent [ Time Frame: Index Hospitalization ]
    Prevalence of acquired methemoglobinemia cases by suspected causal agent

  2. Resolution of Symptoms [ Time Frame: Index Hospitalization ]
    Resolution of methemoglobinemia-related symptoms during the index hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542760


Contacts
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Contact: Alex Frost +1 800 731 9210 ext 9 info@methb.org

Locations
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United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Michele Moyer         
Principal Investigator: Richard Nowak, MD         
Sponsors and Collaborators
Hospital Quality Foundation
Prove pharm
Investigators
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Principal Investigator: Charles V Pollack, MD Hospital Quality Foundation
Additional Information:

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Responsible Party: Hospital Quality Foundation
ClinicalTrials.gov Identifier: NCT03542760    
Other Study ID Numbers: HQF-METHB-2018001
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Keywords provided by Hospital Quality Foundation:
Methylene Blue
Additional relevant MeSH terms:
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Methemoglobinemia
Hematologic Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action