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Methylene Blue as a Third-line Vasopressor in Septic Shock

Primary Purpose

Septic Shock

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Methylene Blue

Phenylephrine

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Methylene Blue, Vasopressors, Septic Shock, Provay Blue®

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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®.

Sites / Locations

Carilion ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Control group

Intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in mean arterial pressure

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

Incidence of acute kidney injury requiring dialysis

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.

Full Information

NCT ID

NCT04089072

First Posted

August 23, 2019

Last Updated

July 22, 2022

Sponsor

Carilion Clinic

Collaborators

Provepharm Life Solutions

1. Study Identification

Unique Protocol Identification Number

NCT04089072

Brief Title

Methylene Blue as a Third-line Vasopressor in Septic Shock

Official Title

Methylene Blue as a Third-line Vasopressor in Septic Shock to Maintain Hemodynamics

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

October 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Carilion Clinic

Collaborators

Provepharm Life Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

Methylene Blue, Vasopressors, Septic Shock, Provay Blue®

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

Experimental

Arm Description

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Methylene Blue

Other Intervention Name(s)

ProvayBlue®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Phenylephrine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in mean arterial pressure

Description

Time Frame

One hour and 24 hours after dose

Secondary Outcome Measure Information:

Title

Incidence of acute kidney injury requiring dialysis

Description

Time Frame

through time of patient discharge, an average of 8 days after admission

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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: 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®.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frank Biscardi, MD

Phone

540-981-7000

fhbiscardi@carilionclinic.org

First Name & Middle Initial & Last Name or Official Title & Degree

Ruth Ndolo, RN

Phone

540-266-6557

rmndolo@carilionclinic.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank Biscardi

Organizational Affiliation

Carilion Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carilion Clinic

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24014

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frank Biscardi

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

To publish aggregated data

Learn more about this trial

Methylene Blue as a Third-line Vasopressor in Septic Shock

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