Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery

• Status: Withdrawn
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a pilot study to determine the hemodynamic effects when hydroxocobalamin vs methylene blue is administered during cardiopulmonary bypass in patients at risk of vasoplegia by measuring mean arterial pressure (MAP), systemic vascular resistance (SVR) and vasopressor requirement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dartmouth-Hitchcock Medical Center
• Treatments: Hydroxocobalamin; Methylene Blue; Vitamin B 12

Criteria

Inclusion Criteria:

1. 60 patients > 18 years of age

2. undergoing coronary artery bypass grafting (CABG) and/or valve surgery on cardiopulmonary bypass (CPB)

3. who have 2 or more preoperative risk factors for vasoplegia1-6:

1. angiotensin-converting enzyme (ACE)-inhibitor, beta-blocker or amiodarone use within 24 hours of surgery

2. anticipated CPB duration greater than 120minutes (combined CABG and valve procedure, >3 planned grafts, > 2 valve surgery)

3. baseline left ventricular ejection fraction (LVEF) of less than 40%.

Exclusion Criteria:

1. Emergency surgery

2. Severe renal insufficiency (preoperative Cr > 1.8)

3. Severe hepatic disease (preoperative diagnosis of liver cirrhosis, or recent elevated liver function tests)

4. Pregnancy or women of childbearing potential

5. Known hypersensitivity to hydroxocobalamin or cyanocobalamin

6. Known hypersensitivity to methylene blue

7. Other known contraindications to methylene blue use: glucose-6-phosphate dehydrogenase (G6PD) deficiency, or ongoing selective serotonin reuptake inhibitor (SSRI), selective norepinephrine reuptake inhibitor (SNRI), tricyclic antidepressant (TCA) or monoamine inhibitor (MAOi) use.