Methylene Blue as a Third-line Vasopressor in Septic Shock

NCT ID: NCT04089072

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2024-11-01

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).

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Phenylephrine

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Methylene Blue

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

ProvayBlue®

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:

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®.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Provepharm Life Solutions

UNKNOWN

Sponsor Role: collaborator

Carilion Clinic

OTHER

Sponsor Role: lead

Responsible Party

Frank H Biscardi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank Biscardi

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

Carilion Clinic

Roanoke, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Frank Biscardi, MD

Role: CONTACT

fhbiscardi@carilionclinic.org

540-981-7000

Ruth Ndolo, RN

Role: CONTACT

rmndolo@carilionclinic.org

540-266-6557

Facility Contacts

Frank Biscardi

Role: primary

Other Identifiers

IRB 19-549

Identifier Type: -

Identifier Source: org_study_id