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Early Initiated Vasopressor Therapy in the Emergency Department

NCT05931601 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2025-07-01

No results posted yet for this study

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.

Conditions

  • Shock
  • Shock, Septic
  • Hypotension
  • Hypotension and Shock
  • Hypotension Symptomatic
  • Hypovolemia
  • Hypovolemic Shock
  • Hypovolemic

Interventions

DRUG

Noradrenaline

See arm description

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Lasse P Bentsen, MD · Department of Emergency Medicine, Odense University Hospital

  • Mikkel Brabrand, MD, PhD · Department of Emergency Medicine, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-08
Primary Completion
2026-12-31
Completion
2027-01-31

Countries

  • Denmark
  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05931601 on ClinicalTrials.gov