Early Initiated Vasopressor Therapy in the Emergency Department
Recruiting
Phase 3
Interventional Study
Shock
Shock, Septic
Hypotension
Hypotension and Shock
Hypotension Symptomatic
Hypovolemia
Hypovolemic Shock
Hypovolemic
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 320 (estimated)
- Sponsor
- Odense University Hospital · Other
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About This Trial
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 nora…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* At least 18 years of age
* Signs or suspicion of hypotension or shock (of any type such as septic, vasodilatory or hypovolemic not included in the exclusion criteria) defined as:
1. SBP \< 100mmHg or MAP \< 65 mmHg combined with lactate \> 2.0 mmol/L,
2. Physician defined…
Contacts