Early Initiated Vasopressor Therapy in the Emergency Department

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Noradrenaline

Treatment groups

320 Participants
are divided into 2 treatment groups

Sponsors and collaborators