Early Initiated Vasopressor Therapy in the Emergency Department

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.

NCT Number	NCT05931601
Lead Sponsor	Odense University Hospital
Conditions	Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia, Hypovolemic Shock, Hypovolemic
Enrollment	320 participants
Start Date	2023-12-08
Primary Completion	2026-12-31 (estimated)
Study Completion	2027-01-31 (estimated)
Updated on ClinicalTrials.gov	2025-07-01