RecruitingPhase 3NCT05931601

Early Initiated Vasopressor Therapy in the Emergency Department

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


Sponsor

Odense University Hospital

Enrollment

320 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Noradrenaline for people with hypotension, hypotension symptomatic, and other related conditions. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNoradrenaline

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

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NCT05931601


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