Methemoglobinemia, AcquiredmetHbNCT03542760
Acquired Methemoglobinemia Observational Registry
An observational study of Methemoglobinemia, Acquired and Methemoglobinemia, run by Hospital Quality Foundation at 32 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Methemoglobinemia, Acquired, Methemoglobinemia
- What is being tested?
- Methylene Blue
- How many people
- 24 participants
- Where
- 32 sitesUnited States
- Study dates
- 31 May 2018to 31 Aug 2021
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.
Who may be able to join
- 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
Who cannot join
- Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
- Treatment of methemoglobinemia with another methylene blue product
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
University of Maryland
Baltimore, Maryland, 21201
Partners Healthcare; Brigham and Women's
Boston, Massachusetts, 02115
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Carolinas Medical Center
Charlotte, North Carolina, 28207
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals
Cleveland, Ohio, 44106
UT Southwestern
Dallas, Texas, 75390
Henry Ford Health System
Detroit, Michigan, 48202
St John Medical Center
Detroit, Michigan, 48236
Hartford Hospital
Hartford, Connecticut, 06106
Baylor College of Medicine
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
IU Health
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
University of Kansas Health System
Kansas City, Kansas, 66160
Cedars Sinai
Los Angeles, California, 90048
University of Tennessee Health Science Center
Memphis, Tennessee, 38104
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
New York Methodist
New York, New York, 10032
University of Nebraska
Omaha, Nebraska, 68198
Palmetto General
Palm Beach Gardens, Florida, 33410
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Oregon Health & Sciences University
Portland, Oregon, 97239
UC Davis Health
Sacramento, California, 95817
HealthPartners Regions
Saint Paul, Minnesota, 55101
University of Washington
Seattle, Washington, 98195
Washington University
St Louis, Missouri, 63110
Tampa General
Tampa, Florida, 33606
Holy Name Medical Center
Teaneck, New Jersey, 07666
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Mercy Health
Youngstown, Ohio, 44501
About this study
Official title: Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
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.
- Conditions
- Methemoglobinemia, Acquired, Methemoglobinemia
- Being tested
- Methylene Blue
- Keywords
- Methylene Blue
- Medical subject headings
- Methemoglobinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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%. Receives: Drug: Methylene Blue | |
| Secondary Treated Group | Subjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms Receives: Drug: Methylene Blue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1h post-treatment
Secondary outcomes (4)
Time to Normalization of Respiratory Rate
Time to normalization of respiratory rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.
Measured: Index Hospitalization
Time to Normalization of Heart Rate
Time to normalization of heart rate after administration of ProvayBlue for treatment of acquired methemoglobinemia.
Measured: Index Hospitalization
Time to Normalization of Blood Pressure
Time to normalization of blood pressure after administration of ProvayBlue for treatment of acquired methemoglobinemia.
Measured: Index Hospitalization
Prevalence and Nature of Adverse Events
Prevalence and nature of any adverse events occurring within 10 days of the administration of ProvayBlue
Measured: Within 10 days of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start31 May 2018
- Primary completion30 Jun 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methemoglobinemia, AcquiredStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Hospital Quality Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Prove pharm
- Responsible party
- Sponsor
- Investigators
- Charles V Pollack, MD, Principal investigator, Hospital Quality Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542760
- Sponsor's protocol ID
- HQF-METHB-2018001
- Acronym
- metHb
- Status last verified
- Apr 2023
- First submitted
- 20 May 2018
- Last updated
- 12 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Methylene Blue in Acquired Methemoglobinemia: Prospective Observational Registry (metHb)
- ClinicalTrials.gov ID
- NCT03542760
- Acronym / sponsor ID
- metHb / HQF-METHB-2018001
- Conditions
- Methemoglobinemia, Acquired, Methemoglobinemia
- Keywords
- Methylene Blue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Quality FoundationUniversity, hospital or other
- Collaborators
- Prove pharm
- Study start
- 31 May 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 31 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Treated Group | – | Drug: Methylene BlueSubjects 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%. |
| Secondary Treated Group | – | Drug: Methylene BlueSubjects who are administered methylene blue for treatment of acquired methemoglobinemia with measured methemoglobin levels ≤ 30 and lack of clinical symptoms |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who present in hospital / urgent care setting diagnosed with acquired methemoglobinemia.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Refusal of consent (in those subjects approached for consent where required by local institutional procedures)
- Treatment of methemoglobinemia with another methylene blue product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylene BlueAdministration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care | Drug | Primary Treated Group, Secondary Treated Group |
Primary outcome
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.
4 secondary outcomes
Time to Normalization of Respiratory Rate
Time frame: Index Hospitalization
Time to Normalization of Heart Rate
Time frame: Index Hospitalization
Time to Normalization of Blood Pressure
Time frame: Index Hospitalization
Prevalence and Nature of Adverse Events
Time frame: Within 10 days of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles V Pollack, MD principal investigator
Hospital Quality Foundation
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methemoglobinemia, Acquired and Methemoglobinemia, run by Hospital Quality Foundation at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of Methemoglobin 1h after Administration of ProvayBlue (time frame: 1h post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.