Methylene Blue as a Third-line Vasopressor in Septic Shock

Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics

A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.

The study will be an un-blinded, Phase 2, randomized, 1:1, prospective trial comparing patients in septic shock receiving norepinephrine and vasopressin followed by phenylephrine versus ProvayBlue® as the third-line vasopressor. The third line vasopressor will be compared at 1 hour to see if it affects the patient's mean arterial blood pressure (MAP).

Inclusion Criteria:

1. Meets Sepsis-3 Criteria (Suspected source of infection plus any 2 criteria of the qSOFA)

2 .Septic Shock (any patient requiring vasopressor therapy to maintain MAP >65 mmHg or any patient with serum lactate >2 mmol/dL even in the absence of hypovolemia ).

3) Greater than 18 years old

4 ) ICU Admission

Exclusion Criteria:

Inability to obtain informed consent from an appropriate surrogate decision maker.

Also:

1. Children less than 18 years old
2. Pregnant women or positive urinary pregnancy test in reproductive-aged women
3. Prisoners
4. Evolving myocardial infarction or known cardiomyopathy with documented EF<35%
5. Known grade 3 diastolic dysfunction document by echocardiogram
6. Known hypersensitivity to thiazine dyes
7. Pulmonary hypertension that is currently requiring vasodilator therapy
8. Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
9. Known documented history of G6PD deficiency or favism
10. Active prior to admission medication prescription for a SSRI or SNRI , systemic heparin anticoagulation or other medications listed above (under Study Agent). These medications will be listed in the printed enrollment form.
11. Severe renal failure is a contraindication to use of ProvayBlue®.