Early initiated vasopressor therapy vs. standard care of primarily fluid therapy in hypotensive patients in the emergency department – A pragmatic, multi-center, superiority, randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504584-16-00

Enrollment

440

Registered

2023-09-11

Start date

2023-12-08

Completion date

Unknown

Last updated

2025-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Shock

Brief summary

The primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion.

Detailed description

Number of ICU free days alive within 30 days, Time without shock within 24 hours, 30-day all-cause mortality., In-hospital all-cause mortality

Interventions

DRUGNOREPINEPHRINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion.	—

Secondary

Measure	Time frame
Number of ICU free days alive within 30 days, Time without shock within 24 hours, 30-day all-cause mortality., In-hospital all-cause mortality	—

Countries

Denmark, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026