None listed
Conditions
Brief summary
This prospective randomized controlled study of patients who are successfully resuscitated following cardiac arrest patients will receive either MeB or placebo, in addition to standard medical care. The study will assess the impact of MeB on overall survival, neurological outcomes, and hemodynamics. We hypothesise that MeB will be safe and effective in improving markers of neuronal injury, with a possible translation to improved mortality. The findings will inform future large-scale research aimed at improving outcomes in this currently highly morbid condition.
Interventions
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Methylene blue (MeB) or Placebo: The study medication will be administered by a registered nurse in the emergency department with the administration recorded on the electronic medical record (EMR) for hospital & study purposes
Methylene Blue (PROVEBLUE 50mg/10mL):
• 2mg/Kg of MeB will be administered over a 5-minute IV push (with the IV flushed using 10mL of normal saline, contained within an opaque syringe)
• Following ad
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Methylene blue (MeB) or Placebo: The study medication will be administered by a registered nurse in the emergency department with the administration recorded on the electronic medical record (EMR) for hospital & study purposes Methylene Blue (PROVEBLUE 50mg/10mL): • 2mg/Kg of MeB will be administered over a 5-minute IV push (with the IV flushed using 10mL of normal saline, contained within an opaque syringe) • Following administration of the bolus, an infusion will be commended at a rate of 0.25mg/kg/hour for a total of 12 hours (opaque bag)
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Methylene blue (MeB) or Placebo: The study medication will be administered by a registered nurse in the emergency department with the administration recorded on the electronic medical record (EMR) for hospital & study purposes
Methylene Blue (PROVEBLUE 50mg/10mL):
• 2mg/Kg of MeB will be administered over a 5-minute IV push (with the IV flushed using 10mL of normal saline)
• Following administration of the bolus, an infusi
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Methylene blue (MeB) or Placebo: The study medication will be administered by a registered nurse in the emergency department with the administration recorded on the electronic medical record (EMR) for hospital & study purposes Methylene Blue (PROVEBLUE 50mg/10mL): • 2mg/Kg of MeB will be administered over a 5-minute IV push (with the IV flushed using 10mL of normal saline) • Following administration of the bolus, an infusion will be commended at a rate of 0.25mg/kg/hour for a total of 12 hours
Sponsors
The Alfred Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 and older • Cardiac arrest of non-traumatic etiology • Shockable first detected rhythm (ventricular fibrillation or ventricular tachycardia) • Total low-flow time (estimated time from cardiac arrest to return of spontaneous circulation (ROSC)) of no greater than 30 minutes. • Randomization within 30 minutes of initial ROSC • Systolic blood pressure <120mmHg or receiving vasoactive medication for hemodynamic support.
Exclusion criteria
• Death considered imminent • Known to be pregnant • Known use of selective serotonin re-uptake inhibitor (SSRI) • Known end stage renal failure • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
Outcome results
None listed