Short summary

VASOSHOCK is a pragmatic multi-center superiority randomized controlled trial. Including 320 ICU-eligible patients ≥18 year with shock.

The intervention group will receive peripherally infused noradrenaline for up to 24 hours to achieve shock control. The control group will receive usual standard of care where ED initiated vasopressor therapy is not available.

Rationale

VASOSHOCK is a pragmatic multi-center superiority randomized controlled trial. Including 320 ICU-eligible patients ≥18 year with shock. Patients with haemorrhagic, anaphylactic, neurogenic, or cardiogenic shock, pregnancy, or breastfeeding will be excluded.

The intervention group will receive peripherally infused noradrenaline for up to 24 hours to achieve shock control. The control group will receive usual standard of care where ED initiated vasopressor therapy is not available.

Description of the cohort

Patients ≥18 year who are hypotensive and ICU eligible, have received at least 500ml fluid prior to inclusion and with a p-lactate ≥2mmol/L will be eligible. Patients with haemorrhagic, anaphylactic, neurogenic, or cardiogenic shock, pregnancy, or breastfeeding will be excluded.

Patients will be randomized using block-randomization stratified by site to either intervention or control.

The intervention group receives peripherally infused noradrenaline of up to 0.15mcg/kg/min for up to 24 hours. The control group will receive standard therapy in the ED, i.e., no noradrenaline infusion available unless admittance to the ICU.

Data and biological material

Primary outcome is defined by either systolic blood pressure >100 mmHg, Mean Arterial Pressure >65mmHg or an individual physician defined treatment goal.

Secondary outcomes:

Number of ICU free days alive within 30 days Hours without shock within 24 hours 30-day all-cause mortality.

In-hospital mortality

Tertiary outcomes:

Proportion of patients receiving vasopressor at any point within 24 hours.

Time to vasopressor initiation

Hours of vasopressor infusion

Proportion of patients developing pulmonary oedema within 72 hours (Diagnosed by physician in accordance with local guidelines, e.g., clinical decision including evaluation with paraclinical imaging such as x-ray or lung ultrasound). Proportion of patients developing acute kidney injury within 72 hours (Defined as an absolute increase of creatinine ≥26.5μmol/L or ≥1.5 fold from baseline)

Lactate level at study entry

Adverse events to peripheral vasopressor infusion, as specified in section 7.0 Safety and harm.

Re-admission within 30 days

ED length of stay

Proportion of patients admitted to the ICU Hospital length of stay

ICU length of stay

Need for mechanical ventilation (either invasive or non-invasive ventilation)

Need for renal replacement therapy (continuous renal replacement therapy or dialysis) Amount of fluid therapy received within the first 24 hours

Collaborating researchers and departments

Department of Emergency Medicine, Odense University Hospital

• Mikkel Brabrand

Department of Emergency Medicine, Zealand University Hospital, Køge

• Gerhard Tiwald

Department of Emergency Medicine, University Hospital Esbjerg

• Peter Biesenbach

Department of Emergency Medicine, Regional Hospital Gødstrup

• Larshan Perinpam