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

Launched by DARTMOUTH-HITCHCOCK MEDICAL CENTER · Feb 20, 2018

Keywords

ClinConnect Summary

Type of study: Randomized, placebo-controlled single-center pilot study Expected duration of subject participation: from the start of cardiac surgical procedure to 24 hours after separation from CPB.

Summary description of sequence and duration of all trial periods:

1. Recruitment and Enrollment: Patients undergoing CABG and/or valve surgery will be approached by their anesthesia provider regarding their interest in participating in this study. Those who express interest will be screened for inclusion and exclusion criteria the morning or day before scheduled surgery. Informed consent wil...

Gender

ALL

Eligibility 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.