Recruiting
Phase 2

Methylene Blue

Sponsor:

Carilion Clinic

Code:

NCT04089072

Conditions

Septic Shock

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Methylene Blue

Phenylephrine

Study Details

Brief summary:

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

Conditions

Septic Shock

Study ID

NCT04089072

Start date

Dec 1, 2019

Status verified date

Jul, 2022

Completion date

Nov 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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®.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Primary outcome measure

  • Change in mean arterial pressure [ Time Frame: One hour and 24 hours after dose ]

Central Contacts and Locations

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

More Information

Sponsor

Carilion Clinic

Last update posted

Jul 26, 2022

Last verified

Jul, 2022

Keywords

  • Methylene Blue
  • Vasopressors
  • Septic Shock
  • Provay Blue®

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2022-07-26.