Methylene Blue as a Third-line Vasopressor in Septic Shock

Last updated: July 22, 2022
Sponsor: Carilion Clinic
Overall Status: Active - Recruiting

Phase

2

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Treatment

N/A

Clinical Study ID

NCT04089072
IRB 19-549
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 anypatient with serum lactate >2 mmol/dL even in the absence of hypovolemia ). 3) Greater than 18 years old

4 ) ICU Admission

Exclusion

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 , systemicheparin anticoagulation or other medications listed above (under Study Agent). Thesemedications will be listed in the printed enrollment form.
  11. Severe renal failure is a contraindication to use of ProvayBlue®.

Study Design

Total Participants: 250
Study Start date:
December 01, 2019
Estimated Completion Date:
November 01, 2024

Study Description

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).

Connect with a study center

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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