None listed
Conditions
Brief summary
Shock is a clinical syndrome which is characterised by cellular and tissue hypoxia due to either inadequate oxygen delivery, increased oxygen demand, or a combination of these processes. It may present on a clinical spectrum ranging from occult hypoperfusion (with preserved blood pressure) to fulminant circulatory collapse. Prompt haemodynamic support of patients with shock is vital to prevent and potentially reverse multi-organ dysfunction. In addition to treating the underlying disease process, intravenous fluid administration constitutes an essential part of the initial management. However, often fluid resuscitation is insufficient and hypotension persists. In this clinical setting vasopressor and/or inotropic medications can be considered. The efficacy of these drugs has largely been assessed though their impact on haemodynamic end-points. Head-to-head comparison between these agents assessing for major clinical outcomes, such as mortality, is limited. However, in small studies of cardiogenic shock, noradrenaline appears to be superior to adrenaline. We aim to compare the efficacy of noradrenaline and adrenaline in the pre-hospital setting in a population experiencing cardiogenic shock
Interventions
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Noradrenaline (trial agent) or Adrenaline (control).
While the trial agent is being prepared, metaraminol 0.5-1.0mg (intravenous) can be administered at 2 minute intervals to maintain perfusion.
Noradrenaline Intravenous Infusion:
• Prepare 3mg noradrenaline diluted to 50mL with 5% dextrose or normal saline
• Commence at 5mcg/min
• Titrate up to 250mcg/min, aiming to achieve SBP greater than or equal to 100mmHg
• Increases
Eligible patients will be randomised in a 1:1 fashion to receive EITHER Noradrenaline (trial agent) or Adrenaline (control). While the trial agent is being prepared, metaraminol 0.5-1.0mg (intravenous) can be administered at 2 minute intervals to maintain perfusion. Noradrenaline Intravenous Infusion: • Prepare 3mg noradrenaline diluted to 50mL with 5% dextrose or normal saline • Commence at 5mcg/min • Titrate up to 250mcg/min, aiming to achieve SBP greater than or equal to 100mmHg • Increases or decreases in dosage should be at a rate of 5-10mcg/min
Sponsors
Ambulance Victoria
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Adult (aged 18 years or older) • Evidence of shock with an indication to commence vasoactive infusion as per Ambulance Victoria Clinical Practice Guidelines and systolic blood pressure <=90mmHg despite adequate filling. • Suspected cardiac aetiology.
Exclusion criteria
• Suspected traumatic, anaphylactic or asthmatic aetiology of shock • Heart rate < 50 beats per minute • Transferred from another healthcare facility • Cardiac arrest with greater than or equal to 30 minutes of cardiopulmonary resuscitation prior to return of spontaneous circulation. • Patient dependent on others for activities of daily living • Female who is known or suspected to be pregnancy • Receiving vasoactive infusion prior to randomisation
Outcome results
None listed