Methylene Blue in Sepsis: A Randomized Controlled Trial

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate whether the addition of Methylene Blue to the standard treatment of septic shock will reduce vasopressor requirements

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen's University
• Collaborator: The Physicians' Services Incorporated Foundation
• Treatments: Methylene Blue; Norepinephrine

Criteria

Inclusion Criteria:

• First presentation of sepsis syndrome: clinical evidence of infection with Systemic Inflammatory Response Syndrome (SIRS)as defined by two or more of:

• Temperature > 38°C or < 36°C,

• Heart rate > 90 beats per minute,

• One or more of respiratory rate > 20, hyperventilation with PaCO2 < 32 mm Hg, requiring mechanical ventilation,

• One or more of white blood cells > 12,000 X 109 /L or white blood cells < 4000 X 109 /L or immature neutrophils > 10%.

• Undergoing early goal directed therapy with a mean arterial blood pressure (MAP) < 65 mmHg despite fluid resuscitation to CVP > 10mmHg.

• Able to provide informed consent as per our institutional standard.

• To receive first dose of study drug within six hours of first recorded hypotension (MAP < 65mmHg).

Exclusion Criteria:

• Age < 18 years.

• Undergoing palliation.

• Not expected to survive 48 hours.

• Resuscitated from a vital sign absent arrest.

• Ongoing dialysis.

• Anuric or creatinine > 300 μmol/L.

• Pregnant.

• Patient or family history of glucose-6-phosphate dehydrogenase deficiency.

• Allergic to methylene blue, phenothiazines, thiazide diuretics, or food dyes.

• Patient mass > 150 kg.

• Demonstrated Pulmonary Hypertension (Mean Pulmonary Artery Pressure > 25 mmHg by Swan Ganz Catheter or Echo demonstrated Right Ventricular Systolic Pressure > 40 mmHg).