Methylene Blue as a Third-line Vasopressor in Septic Shock

  • STATUS
    Recruiting
  • End date
    Nov 1, 2024
  • participants needed
    250
  • sponsor
    Carilion Clinic
Updated on 4 October 2022
lactic acid
sepsis
vasoconstrictor
lactate level

Summary

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

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).

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

Eligibility

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
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
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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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