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

What Was Tested

This registered phase 2 trial tested Methylene blue (non-peptide stack partner) and Cyanocobalamin (Vitamin B12).

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.

It had three arms (groups): Hydroxocobalamin (experimental), Methyelene blue (experimental) and Normal saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

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 will be obtained from participants by study personnel. 2.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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).

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: emergency surgery; severe renal insufficiency (preoperative cr \> 1.8); severe hepatic disease (preoperative diagnosis of liver cirrhosis, or recent elevated liver function tests).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2019-11 with completion listed for 2020-05.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: ΔMAP (baseline to 30 min after CPB separation) in OH-CO and placebo groups (time frame: From baseline to 30 minutes after successful separation from cardiopulmonary bypass (CPB)).

It also tracked 8 secondary outcomes, for example ΔMAP (baseline to 30 min after CPB separation) in OH-CO and MB groups, ΔSVR (baseline to 30 min after CPB separation) in OH-CO and placebo groups, ΔSVR (baseline to 30 min after CPB separation) in OH-CO and MB groups, Differences in phenylephrine requirements during CPB between all 3 groups during CPB, Differences in Norepinephrine requirements during CPB between all 3 groups during and after CPB and Differences in Vasopressin requirements during CPB between all 3 groups during and after CPB.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) and Cyanocobalamin (Vitamin B12) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page and the Cyanocobalamin (Vitamin B12) compound page, all human trials.