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Methylene Blue as a Third-line Vasopressor in Septic Shock

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ClinicalTrials.gov Identifier: NCT04089072
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : July 26, 2022
Sponsor:
Collaborator:
Provepharm Life Solutions
Information provided by (Responsible Party):
Frank H Biscardi, Carilion Clinic

Study Description
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Brief Summary:
A randomized, prospective study comparing ProvayBlue® to standard care with multiple sympathomimetic vasopressors.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Methylene Blue Drug: Phenylephrine Phase 2

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 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : November 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Control group
Patients in the control group will have phenylephrine infusion starting at 50 mcg/min and titrated to maintain a MAP >65 mmHg as a third line vasopressor. Maximum dose of Phenylephrine is 300 mcg/min.
 Drug: Phenylephrine

Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin) already , they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor.

Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock.
Experimental: Intervention group
Patients enrolled in the intervention group will receive 2 mg/kg IBW (Ideal Body Weight) bolus, given over 15 mins, of ProvayBlue® followed by a concomitant infusion at 2 mg/kg/hr (IBW) mixed in D5W, which will continue for 24 hours. ProvayBlue® ( Methylene Blue) will be used as the third-line vasopressor.
 Drug: Methylene Blue

Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin), they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor.

Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock.

Other Name: ProvayBlue®


Outcome Measures
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Primary Outcome Measures :
  1. Change in mean arterial pressure [ Time Frame: One hour and 24 hours after dose ]
    The primary objective is to determine if the administration of ProvayBlue® is non-inferior to the use of phenylephrine as a third-line vasopressor to keep a mean arterial pressure (MAP)>65 mmhg after one hour and at 24 hours after the initiation of the drugs.


Secondary Outcome Measures :
  1. Incidence of acute kidney injury requiring dialysis [ Time Frame: through time of patient discharge, an average of 8 days after admission ]
    The secondary objectives are to see if the total vasopressor dosing and renal replacement needs are different in those patients receiving ProvayBlue® rather than standard care with escalating number of vasopressors.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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®.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089072


Contacts
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Contact: Frank Biscardi, MD 540-981-7000 fhbiscardi@carilionclinic.org
Contact: Ruth Ndolo, RN 540-266-6557 rmndolo@carilionclinic.org

Locations
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United States, Virginia
Carilion Clinic Recruiting
Roanoke, Virginia, United States, 24014
Contact: Frank Biscardi         
Sponsors and Collaborators
Carilion Clinic
Provepharm Life Solutions
Investigators
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Principal Investigator: Frank Biscardi Carilion Clinic
More Information
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Responsible Party: Frank H Biscardi, MD, Carilion Clinic
ClinicalTrials.gov Identifier: NCT04089072    
Other Study ID Numbers: IRB 19-549
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To publish aggregated data

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Frank H Biscardi, Carilion Clinic:
Methylene Blue
Vasopressors
Septic Shock
Provay Blue®
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Phenylephrine
Oxymetazoline
Methylene Blue
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors