Methylene Blue as a Third-line Vasopressor in Septic Shock

• Status: Recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carilion Clinic
• Collaborator: Provepharm Life Solutions
• Treatments: Benzocaine; Methylene Blue; Oxymetazoline; Phenylephrine; Vasoconstrictor Agents

Criteria

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®.