Status:
UNKNOWN
Methylene Blue as a Third-line Vasopressor in Septic Shock
Lead Sponsor:
Carilion Clinic
Collaborating Sponsors:
Provepharm Life Solutions
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Inability to obtain informed consent from an appropriate surrogate decision maker.
- Also:
- Children less than 18 years old
- Pregnant women or positive urinary pregnancy test in reproductive-aged women
- Prisoners
- 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
- Known documented history of G6PD deficiency or favism
- 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.
- Severe renal failure is a contraindication to use of ProvayBlue®.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT04089072
Start Date
December 1 2019
End Date
November 1 2024
Last Update
July 26 2022
Active Locations (1)
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1
Carilion Clinic
Roanoke, Virginia, United States, 24014