Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID05931601

Early Initiated Vasopressor Therapy vs. Standard Fluid Therapy in Hypotensive Patients in the Emergency Department - A Randomized Controlled Trial

Led by Odense University Hospital · Updated on 2025-07-01

320

Participants Needed

8

Research Sites

4 weeks

Total Duration

On this page

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 mcg/kg/min 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

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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

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

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Research Team

L

Lasse P Bentsen, MD

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...

https://pubmed.ncbi.nlm.nih.gov/40197397