Comparing Early Noradrenaline Infusion with Standard Fluid Therapy for Treating Low Blood Pressure and Shock in Emergency Departments
Led by Odense University Hospital · Updated on 2025-07-01
320
Participants Needed
8
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating early treatment with peripheral intravenous noradrenaline compared to standard fluid therapy in adults with low blood pressure or shock in Danish and Swedish Emergency Departments. The study aims to see if early noradrenaline can help control shock faster, reduce ICU admissions, and lower mortality rates. This is a pragmatic, multi-center, randomized trial focused on improving emergency care for hypotensive patients.
Participants will be randomly assigned to receive noradrenaline infused at 0.05-0.15 mcgkgmin for up to 24 hours in the Emergency Department until shock control is achieved. If shock control is not reached within 24 hours, or treatment cannot be stopped, patients will be transferred to the ICU for further care without continuing the trial intervention. The comparison group will receive standard care, which includes fluid therapy and ICU transfer if needed but no noradrenaline during the ED stay.
During the study, patient data will be collected from bedside monitoring, electronic health records, and national registries. One year after enrollment, participants will be contacted to assess their physical function and daily self-care ability. The primary outcome measures the proportion of patients achieving target blood pressure 90 minutes after inclusion. Secondary outcomes include ICU-free days alive within 30 days, time without shock within 24 hours, and mortality rates at 30 days and hospital discharge.
CONDITIONS
Brief Title
Early Initiated Vasopressor Therapy in the Emergency Department
Research Team
L
Lasse P Bentsen, MD
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Signs or suspicion of hypotension or shock defined by either systolic blood pressure below 100 mmHg or mean arterial pressure below 65 mmHg combined with lactate above 2.0 mmol/L, or physician-defined blood pressure with lactate above 2.0 mmol/L
Received at least 500 ml of intravenous fluids within the first 4 hours of Emergency Department arrival
Clinical Frailty Score of 4 or less, or higher score if considered suitable for ICU admission by treating and ICU physicians
You will not qualify if you...
Suspected cardiogenic, anaphylactic, hemorrhagic, or neurogenic shock
Fertile women under 60 years old who are pregnant or breastfeeding
Patients deemed terminally ill or with severe co-morbidities making them ineligible for ICU admission
Known allergy to noradrenaline
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 24 hours after randomization
Participants receive either early initiated peripheral noradrenaline infusion for up to 24 hours in the Emergency Department or standard fluid therapy without noradrenaline.
1 to 2 visits during the treatment period in the Emergency Department
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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Published Research Related To This Trial
Early initiated noradrenaline versus fluid therapy for hypotension and shock in the emergency department (VASOSHOCK): a protocol for a pragmatic, multi-center, superiority, randomized controlled trial.
Lasse Paludan Bentsen, Thomas Strøm, Jakob Lundager Forberg...