RecruitingACTRN12621000730808

Methylene Blue in the Assessment of Gain In Cardiac Surgical Post-Operative vasoplegia (MAGIC) trial

A multicentre, parallel group, single-blind, randomised clinical trial investigating the effect of the use of Methylene Blue on days free of vasopressor support in Vasoplegic Patients After Cardiac Surgery.


Sponsor

Medical Research Institute of New Zealand

Enrollment

177 participants

Start Date

Feb 2, 2022

Study Type

Interventional

Conditions

Summary

Nitric oxide is a chemical released from blood vessel walls and causes vasodilation and low blood pressure known as vasodilatory shock. Vasodilation by this mechanism often occurs in patients who undergo surgeries which need heart lung bypass such as cardiac surgery and can be resistant to normal blood pressure supporting medications. This condition is called vasoplegia. In such patients, methylene blue, which is a common drug that opposes nitric oxide-induced effects on blood vessels may potentially provide a mechanism to reduce the need for blood pressure support in patients having cardiac surgery. Only one previous randomised controlled trial has evaluated the use of methylene blue in patients with post cardiac surgery vasoplegia. A total of 638 patients were screened with 56 who developed post cardiopulmonary vasoplegia included in the trial. Of these, 28 received an infusion of 1.5 mg/kg of methylene blue over 1 hour and 28 received placebo. Mortality was 0% for the methylene blue group and 21.4% in the placebo group. There was also a significant difference in the duration of blood pressure support with all patients in the methylene blue group being successfully weaned from support within 4 hours of the treatment. These results are suggestive of a significant benefit to the routine use of Methylene blue in this group. The objective of the MAGIC trial is to test the hypothesis is that in adults who are invasively mechanically ventilated in the ICU following cardiac surgery with clinically significant vasoplegia who are receiving high doses of blood pressure medications, does a methylene blue infusion at a rate of 1.5mg/kg/hour for one hour increase hours alive and free from blood pressure support at day 10 post randomisation when compared with placebo.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

After cardiac surgery requiring heart-lung bypass, a small but serious number of patients develop a condition called vasoplegia — a sudden and severe drop in blood pressure caused by excessive widening of the blood vessels, driven by nitric oxide. This can be resistant to standard blood pressure-supporting medications. Methylene blue is a drug that blocks nitric oxide's effect on blood vessels and may reverse this dangerous drop in blood pressure. A small previous trial suggested it dramatically reduced mortality in these patients. The MAGIC trial is testing this finding on a larger scale. Patients in the ICU after cardiac surgery who are on high doses of vasopressor medications and show signs of vasoplegia are randomly assigned to receive either a methylene blue infusion or a placebo. The main outcome is the number of hours patients are alive and free from blood pressure support. You may be eligible if you are 18 or over, have recently undergone cardiac surgery with cardiopulmonary bypass, are currently on mechanical ventilation in the ICU, and require high doses of noradrenaline to maintain blood pressure, with evidence suggesting vasoplegia is the cause. People with an allergy to methylene blue, G6PD deficiency, or who normally take antidepressants (SSRIs) are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intravenous methylene blue infusion at a rate of 1.5mg/kg/hour for one hour. Patients will be assessed by research staff for inclusion in the study within 24 hours of admission to ICU immediately fo

Intravenous methylene blue infusion at a rate of 1.5mg/kg/hour for one hour. Patients will be assessed by research staff for inclusion in the study within 24 hours of admission to ICU immediately following cardiac surgery. The intervention will be provided to the bedside staff and administered within 1 hour of randomisation.


Locations(4)

Austin Health - Austin Hospital - Heidelberg

WA,VIC, Australia

Fiona Stanley Hospital - Murdoch

WA,VIC, Australia

Sir Charles Gairdner Hospital - Nedlands

WA,VIC, Australia

Wellington, New Zealand

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ACTRN12621000730808