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Early Initiated Vasopressor Therapy in the Emergency Department
Sponsor: Odense University Hospital
Summary
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.
Official title: Early Initiated Vasopressor Therapy vs. Standard Care of Primarily Fluid Therapy in Hypotensive Patients in the Emergency Department - A Pragmatic, Multi-center, Superiority, Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
320
Start Date
2023-12-08
Completion Date
2027-01-31
Last Updated
2025-07-01
Healthy Volunteers
No
Conditions
Interventions
Noradrenaline
See arm description
Locations (8)
Bispebjerg Hospital
Copenhagen, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Gødstrup Regional Hospital
Herning, Denmark
Zealand University Hospital
Køge, Denmark
Odense University Hospital
Odense, Denmark
Department of Emergency Medicine
Helsingborg, Sweden
Department of Emergency Medicine
Linköping, Sweden
Department of Emergency Medicine
Ystad, Sweden