In short
Noradrenaline hydrochloride is a chemical substance that acts as a vasopressor, meaning it narrows blood vessels to raise blood pressure. It is authorised as a medicine and is being investigated in a Phase 3 trial involving 280 participants to see whether starting it early in the emergency department helps control shock and hypotension faster than fluid therapy alone.
Key points
- Noradrenaline hydrochloride is a vasopressor used to raise blood pressure in conditions like shock and hypotension.
- A Phase 3 trial (NCT05931601) is testing early noradrenaline treatment in the emergency department for non-bleeding hypotensive patients.
- The trial plans to enrol 280 participants and is currently authorised.
- The main outcome is the proportion of patients reaching a target blood pressure (SBP >100 mmHg or MAP >65 mmHg) within 90 minutes.
- Noradrenaline is given as a concentrate for solution for infusion by intravenous infusion.
- The study compares early vasopressor therapy with fluid therapy alone.
What is noradrenaline hydrochloride?
Noradrenaline hydrochloride, also known as norepinephrine, is a chemical substance classified as a sympathomimetic amine. It is a precursor of adrenaline that is naturally secreted by the adrenal medulla and acts widely in the central and peripheral nervous system. Other names for the same substance include arterenol, levarterenol, and norepinephrine bitartrate. It is an authorised medicine available as a concentrate for solution for infusion, for example as a 1 mg/ml product.
How does noradrenaline hydrochloride work?
Noradrenaline acts on adrenergic receptors in the body. On peripheral noradrenergic nerve endings, activation of presynaptic beta-adrenoreceptors can enhance the release of noradrenaline in response to nerve stimulation. These presynaptic beta-adrenoreceptors do not appear to be activated by neuronally released noradrenaline itself, but adrenaline may act as a physiological activator during enhanced adrenal secretion. In the central nervous system, noradrenaline has a regulatory role in human attention, and drugs that increase noradrenaline tone have been shown to improve attention in experimental settings. Clinically, noradrenaline is used as a vasopressor: it narrows blood vessels, which raises blood pressure in patients with dangerously low blood pressure.
Which conditions is noradrenaline hydrochloride used or studied for?
- Shock – a life-threatening condition where blood pressure drops so low that organs do not get enough blood. The VASOSHOCK trial is studying whether early noradrenaline can control shock faster.
- Hypotension – abnormally low blood pressure. The same trial includes non-bleeding hypotensive patients presenting in the emergency department.
How is noradrenaline hydrochloride given?
Noradrenaline hydrochloride is available as a concentrate for solution for infusion and is given by intravenous infusion. In the VASOSHOCK trial, the intervention is described as an intravenous infusion of norepinephrine.
What do the clinical trials show?
One trial is registered for noradrenaline hydrochloride in shock and hypotension. The VASOSHOCK trial is a Phase 3, multi-centre, randomised controlled trial that plans to enrol 280 participants. It is currently authorised.
What is the trial measuring?
The primary outcome is the proportion of patients achieving either a systolic blood pressure (SBP) greater than 100 mmHg, a mean arterial pressure (MAP) greater than 65 mmHg, or a target blood pressure set by the treating physician at 90 minutes (plus or minus 15 minutes) after inclusion. The aim is to investigate whether early vasopressor therapy, compared to fluid therapy alone, can improve the time to shock control and reduce the need for intensive care unit admission.
Who can take part in the trial?
The trial includes non-bleeding hypotensive patients presenting in the emergency department. It compares early initiated vasopressor therapy with noradrenaline against fluid therapy alone.