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RecruitingNCT05931601

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

Status
Recruiting
Phase
Phase 3
Study type
Interventional
Enrollment
320 (estimated)
Sponsor
Odense University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

Please refer to the full protocol.

Conditions

Interventions

TypeNameDescription
DRUGNoradrenalineSee arm description

Timeline

Start date
2023-12-08
Primary completion
2026-12-31
Completion
2027-01-31
First posted
2023-07-05
Last updated
2025-07-01

Locations

8 sites across 2 countries: Denmark, Sweden

Source: ClinicalTrials.gov record NCT05931601. Inclusion in this directory is not an endorsement.