The aim is to investigate whether the use of early initiated vasopressor therapy (i.e., noradrenaline) compared to fluid therapy alone in non-bleeding hypotensive patients presenting in the ED can improve time to shock control and by that, reduce the need for ICU admittance.

Short background

Shock and hypotension are critical conditions in the Emergency Department (ED) with a high mortality and morbidity for affected patients. Fluid therapy is the mainstay treatment of hypotension and shock in Danish ED’s, where vasopressor therapy is not currently available. The lack of these treatments in the routine care of this critically ill patient could, impose risk of excessive fluid therapy for shock control and by that risk further harm during the ED stay.

Vasopressor therapy is commonly provided in shock and recent studies internationally show that earlier initiation can lead to fasther shock control, but current trial data is still sparse. Other trials undergoing evaluate the usage of early peripheral vasopressor therapy in settings where vasopressor therapy is routine use in the ED and will not have the same possibility for evaluating vasopressor against fluid therapy only ED resuscitation.

Methods

VASOSHOCK is a pragmatic multi-center superiority randomized controlled trial assessing ICU eligible patients of ≥18 year old, who have hypotension or shock (with either lactate >2 mmol/L or obvious signs of shock). Patients will receive at least 500ml fluid prior to inclusion.

Shock of any type can be included, except haemorrhagic, anaphylactic, neurogenic, or cardiogenic shock.

Patients are randomized using block-randomization stratified by site to either intervention with noradrenalin and stadard care or control with standard care.

The intervention group will receive peripherally infused noradrenaline up to 0.15mcg/kg/min for up to 24 hours for shock control defined by either systolic blood pressure >100 mmHg, Mean Arterial Pressure >65mmHg or an individual physician defined treatment goal for patients who might require other blood pressure targets (due to known low or high blood pressure).

The control group will receive usual standard of care where ED initiated vasopressor therapy is not available.

Primary and key secondary outcomes

Primary
The primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion.

Key secondary
Number of ICU free days alive within 30 days
Time without shock within 24 hours
30-day all-cause mortality.
In-hospital all-cause mortality

Perspectives

A short time to initiation of vasopressor for the treatment of shock, compared to current practice in the Danish ED’s, could lead to better outcomes.

Earlier initiation might lead to shorter time to shock control and decrease need for ICU admittance and treatment, also when considering possible complications from excessive fluid therapy.

Evaluation of vasopressor usage in the Danish ED setting, where these are not routinely available, could provide insight in the safety of implementation in vasopressor treatment naive departments.

Trial registration

EU CT ID: 2023-504584-16-00
Clinicaltrials.gov: NCT05931601