Methylene Blue as a Third-line Vasopressor in Septic Shock

  • End date
    Nov 1, 2024
  • participants needed
  • sponsor
    Carilion Clinic
Updated on 4 October 2022
lactic acid
lactate level


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).

Condition Septic Shock
Treatment Phenylephrine, Methylene blue
Clinical Study IdentifierNCT04089072
SponsorCarilion Clinic
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Meets Sepsis-3 Criteria (Suspected source of infection plus any 2 criteria of the qSOFA)
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 )
) Greater than 18 years old
) ICU Admission

Exclusion Criteria

Inability to obtain informed consent from an appropriate surrogate decision maker
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%
Known grade 3 diastolic dysfunction document by echocardiogram
Known hypersensitivity to thiazine dyes
Pulmonary hypertension that is currently requiring vasodilator therapy
Concurrent form of shock present or suspected: Obstructive, Neurogenic, Hemorrhagic
Active prior to admission medication prescription for a SSRI or SNRI , systemic
Known documented history of G6PD deficiency or favism
heparin anticoagulation or other medications listed above (under Study Agent). These
medications will be listed in the printed enrollment form
Severe renal failure is a contraindication to use of ProvayBlue®
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