RecruitingPhase 3ACTRN12621000805875

Paramedic Randomized Trial of Noradrenaline Versus Adrenaline in the Initial Management of Patients with Cardiogenic Shock: The PANDA Trial

Paramedic Randomized Trial of Noradrenaline Versus Adrenaline in the Initial Management of Patients with Cardiogenic Shock: Investigating the effect on 28-day mortality


Sponsor

Ambulance Victoria

Enrollment

1,155 participants

Start Date

Feb 28, 2024

Study Type

Interventional

Conditions

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


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Cardiogenic shock is a critical, life-threatening condition where the heart is too weak to pump enough blood around the body — often following a heart attack. In this emergency setting, vasopressor medications are used to support blood pressure and maintain blood flow to vital organs. Two key drugs used for this are adrenaline (epinephrine) and noradrenaline (norepinephrine), but there is limited evidence on which one is more effective and safer. The PANDA Trial will be the first study to compare these two drugs when administered by paramedics in the pre-hospital setting — in the ambulance before hospital arrival — in patients experiencing cardiogenic shock. The trial aims to determine whether noradrenaline produces better clinical outcomes than adrenaline in this time-critical situation. You may be eligible if you are an adult aged 18 or older with signs of shock believed to be caused by a cardiac problem, and your systolic blood pressure is 90mmHg or below despite fluid treatment. People with shock from trauma, allergy, or asthma, those with a very slow heart rate, patients transferred from another facility, or those with cardiac arrest lasting over 30 minutes before resuscitation would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 (intraven

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


Locations(1)

VIC, Australia

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