NCT05931601: VASOSHOCK

Early Initiated Vasopressor Therapy in the Emergency Department

Recruiting now Phase 3 Last updated 1 July 2025

What this trial tests

Phase 3 trial testing Noradrenaline in Shock in 320 participants. Currently enrolling.

Timeline

8 December 2023

Primary endpoint
31 December 2026

31 January 2027

Quick facts

Lead sponsor	Odense University Hospital
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	320
Start date	8 December 2023
Primary completion	31 December 2026
Estimated completion	31 January 2027
Sites	8 locations across Denmark, Sweden

Drugs / interventions tested

• Noradrenaline — full drug profile →

Conditions studied

• Shock — all drugs for Shock →
• Shock, Septic — all drugs for Shock, Septic →
• Hypotension — all drugs for Hypotension →
• Hypotension and Shock — all drugs for Hypotension and Shock →

Sponsor

Odense University Hospital

Who can join

18 and older, any sex, with Shock or Shock, Septic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Early norepinephrine for patients with septic shock: an updated systematic review and meta-analysis with trial sequential analysis.
   Shi R, Braïk R, Monnet X, Gu WJ, et al · · 2025 · cited 8× · PMID 40329359 · DOI 10.1186/s13054-025-05400-z
2. 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.
   Bentsen LP, Strøm T, Forberg JL, Tiwald G, et al · · 2025 · PMID 40197397 · DOI 10.1186/s13049-025-01369-4