The goal of this pragmatic, multi-center, superiority, randomized clinical trial is to compare early treatment with peripheral (through a vein) infused noradrenaline (a natural hormone that increases blood pressure) with fluid only therapy in patients with hypotensive and shock in the Danish and Swedish Emergency Departments (ED).
The main questions it aims to answer are:
If early initiated noradrenaline in non-bleeding hypotensive patients presenting in the ED can
* Improve time to shock control. * Reduce the need for ICU admittance. * Decrease mortality.
Participants will be included by the clinical staff and treated urgently with either noradrenaline or usual treatment during their Emergency Department stay.
After completion of the treatment in the Emergency Department, patient data will be extracted from the bed-side measurements, electronic health records and national registers.
Patients will be contacted by the research staff 1 year after study inclusion to answer brief questions about their daily physical function and ability to care for themselves.
Researchers will compare with patients receiving fluid therapy only, as this is the usual standard of care in Danish and Swedish Emergency Departments.
At least 18 years of age
Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the
SBP < 100mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L,
Physician defined blood pressure for the individual patient combined with a lactate > 2.0 mmol/L
Either SBP < 100mmHg or MAP < 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician.
Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival.
Parallel
Noradrenaline
DrugSee arm description
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.
Bed-side assessment during treatment and registered in the case report form.
Number of intensive care unit (ICU) free days alive within 30 days
Data is extracted from the Danish national registries or the patient's electronic medical record. Note: Death will count as 0 days.
Time without shock within 24 hours
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
30-day all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
In-hospital all-cause mortality
Data is extracted from the Danish national registries or the patient's electronic medical records.
Proportion of patients receiving vasopressor at any point within 24 hours
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Time to vasopressor initiation
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Hours of vasopressor infusion
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Proportion of patients with pulmonary oedema within 72 hours
Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
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