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

Not Applicable

Recruiting

Conditions: Post-operative Cardiothroacic surgical vasoplegia
Cardiovascular - Other cardiovascular diseases
Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system
Surgery - Other surgery

Registration Number: ACTRN12621000730808

Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 177

Inclusion Criteria

1) Greater than or equal to 18 years of age
2) Invasively mechanically ventilated in ICU within 24 hours of ICU
admission and receiving greater than or equal to 10mcg/min of noradrenaline to
support mean arterial pressure following cardiac surgery with
cardiopulmonary bypass.
3) The clinician considers that vasoplegia is a significant contributor to the
haemodynamic disturbance AND this impression is supported by
either:
3.1 a cardiac index greater than or equal to 2.5L/min/m2
OR,
3.2 a central venous oxygen saturation greater than or equal to 60%

Exclusion Criteria

1. Death is deemed to be inevitable as a result of the current acute illness
and either the treating clinician, the patient, or the substitute decision
maker are not committed to full active treatment.
2. The patient has mechanical cause of shock such as cardiac
tamponade or tension pneumothorax.
3. Mechanical support (e.g. IABP, IMPELLA, or ECMO) or post heart
transplant.
4. Enrolment not considered in the patient’s best interest.
5. Patient has an established indication for Methylene Blue
6. Allergy to methylene blue
7. Glucose-6-phosphate dehydrogenase deficiency (risk of haemolytic
anaemia).
8. Usually prescribed an SSRI.
9. Pregnant or breast feeding
10. Has already received methylene blue during this hospital admission
11. Previously enrolled in the MAGIC study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The composite outcome of Hours alive and free from vasopressors at day 10 post-randomisation. <br><br>This will be assessed by review of both the medication administration records and the medical records.<br><br>All patients who die within 90 days prior to hospital discharge will be assigned negative one hours alive and free from vasopressors in order that all patients who die are assigned a worse outcome than all patients who survive. [ Day 10 post-randomisation]

Secondary Outcome Measures