Actively Recruiting
Early Initiated Vasopressor Therapy in the Emergency Department
Led by Odense University Hospital · Updated on 2025-07-01
320
Participants Needed
8
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Initiated Vasopressor Therapy in the Emergency Department
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age
- Signs or suspicion of hypotension or shock defined as either SBP < 100 mmHg or MAP < 65 mmHg combined with lactate > 2.0 mmol/L, or physician-defined low blood pressure with lactate > 2.0 mmol/L, or SBP < 100 mmHg or MAP < 65 mmHg with obvious signs of shock evaluated by physicians
- Received at least 500 ml of intravenous fluid before study inclusion within the first 4 hours of Emergency Department arrival
- Clinical Frailty Score of 4 or less, or if higher, ICU admission eligibility confirmed by treating and ICU physicians
You will not qualify if you...
- Suspected cardiogenic, anaphylactic, hemorrhagic, or neurogenic shock
- Fertile women under 60 years old with positive pregnancy tests or who are breastfeeding
- Patients deemed terminally ill or with severe co-morbidities making ICU admission inappropriate
- Known allergy to noradrenaline
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Actively Recruiting
2
Esbjerg Hospital
Esbjerg, Denmark, 6700
Terminated
3
Gødstrup Regional Hospital
Herning, Denmark, 7400
Not Yet Recruiting
4
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
5
Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
6
Department of Emergency Medicine
Helsingborg, Sweden, 25223
Not Yet Recruiting
7
Department of Emergency Medicine
Linköping, Sweden, 58185
Not Yet Recruiting
8
Department of Emergency Medicine
Ystad, Sweden, 27133
Not Yet Recruiting
Research Team
L
Lasse P Bentsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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