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

Withdrawn before enrolling · Phase 2

Conditions studied: Vasoplegia, Hypotension, Coronary Artery Disease, Cardiac Valve Disease

In brief

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.

Key facts

Study ID

NCT03446599

Run by

Dartmouth-Hitchcock Medical Center

People needed

0

Starts

2019-11-01

Expected to finish

2020-06-30

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 60 patients > 18 years of age
• undergoing coronary artery bypass grafting (CABG) and/or valve surgery on cardiopulmonary bypass (CPB)
• who have 2 or more preoperative risk factors for vasoplegia1-6:
• angiotensin-converting enzyme (ACE)-inhibitor, beta-blocker or amiodarone use within 24 hours of surgery
• anticipated CPB duration greater than 120minutes (combined CABG and valve procedure, >3 planned grafts, > 2 valve surgery)
• baseline left ventricular ejection fraction (LVEF) of less than 40%.

You may not qualify if…

• Emergency surgery
• Severe renal insufficiency (preoperative Cr > 1.8)
• Severe hepatic disease (preoperative diagnosis of liver cirrhosis, or recent elevated liver function tests)
• Pregnancy or women of childbearing potential
• Known hypersensitivity to hydroxocobalamin or cyanocobalamin
• Known hypersensitivity to methylene blue
• 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.

Where it is running

• Dartmouth-Hitchcock — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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