Status:
WITHDRAWN
Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Conditions:
Vasoplegia
Hypotension
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 art...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03446599
Start Date
November 1 2019
End Date
June 30 2020
Last Update
March 2 2020
Active Locations (1)
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1
Dartmouth-Hitchcock
Lebanon, New Hampshire, United States, 03756