Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05931601
PHASE3

Early Initiated Vasopressor Therapy in the Emergency Department

Sponsor: Odense University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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