Methylene Research
A randomized, prospective, non-blinded study to investigate the improvement of mean arterial pressure (MAP) at 1 hour by comparing methylene blue (ProvayBlue®) to phenylephrine as a third-line vasopressor.
About
Protocol Description
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors to determine whether the administration of ProvayBlue® is non-inferior to the use of phenylephrine as a third-line vasopressor to keep a mean arterial pressure (MAP)>65 mmHg after one hour and at 24 hours after the initiation of the drugs.
Eligibility Criteria
- Must be at least 18 years of age
- Meets sepsis-3 criteria and in septic shock
- ICU admission
Exclusion Criteria
- Children less than 18 years old
- Pregnant women or positive urinary pregnancy test in reproductive-aged women
- Evolving myocardial infarction or known cardiomyopathy with documented EF<35%
- Concurrent form of shock present or suspected: obstructive, neurogenic, hemorrhagic
- Severe renal failure
Principal Investigator
Frank H. Biscardi, MD is a pulmonary and critical care medicine physician at Carilion Clinic Pulmonary and Sleep Medicine.