Methylene Blue as a Third-line Vasopressor in Septic Shock

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04089072
• Other study ID #: IRB 19-549
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2019
• Est. completion date: November 1, 2024

Study information

• Verified date: July 2022
• Source: Carilion Clinic
• Contact: Frank Biscardi, MD
• Phone: 540-981-7000
• Email: fhbiscardi[@]carilionclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: November 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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®.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Carilion Clinic	Roanoke	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Carilion Clinic	Provepharm Life Solutions

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One hour and 24 hours after dose
Secondary	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.	through time of patient discharge, an average of 8 days after admission