Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Sweden / NCT05931601
Recruiting Phase 3

Early Initiated Vasopressor Therapy in the Emergency Department

NCT05931601 · tracked via the Priya Life Science Sweden tracker
Sponsor
Odense University Hospital
Phase
Phase 3
Started
2023-12-08
Last updated
2025-07-01

Condition(s) studied

ShockShock, SepticHypotensionHypotension and ShockHypotension SymptomaticHypovolemiaHypovolemic ShockHypovolemic

Investigational drug(s) / intervention(s)

Noradrenaline →

Noradrenaline: See arm description

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 blood pressure for the individual patient combined with a lactate \> 2.0 mmol/L 3. Either SBP \< 100mmHg or MAP \< 65mmHg with obvious signs of shock with any lactate level evaluated by either two non-specialist physicians (e.g. registrar medical doctors) or a specialist physician. * Received at least 500ml of intravenous fluid before study inclusion (Including prehospital administration) within the first 4 hours of ED arrival. * Clinical Frailty Score (CFS) of ≤4. If CFS is ≥5 and the treating physician find the patient suitable for ICU admittance, the participant can be enrolled, if the on-call ICU doctor would accept the patient for ICU admittance. If the treating physician is unsure of ICU eligibility, regardless of CFS score, the patient should be consulted with the ICU consultant before study inclusion. Exclusion Criteria: * Cardiogenic, anaphylactic, haemorrhagic, or neurogenic shock suspected by the treating physician. * Fertile women (\<60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG or women breastfeeding. * Patient deemed terminally ill or with a severe co-morbid status resulting in non-eligibility for ICU admittance decided by either the treating physician or ICU consultant. * Known allergy to noradrenaline.

Primary outcome measure(s)

  • 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. — At 90 minutes
    Bed-side assessment during treatment and registered in the case report form.

Trial sites (8)

FacilityCityRegionStatus
Bispebjerg Hospital Copenhagen Denmark Recruiting
Esbjerg Hospital Esbjerg Denmark Terminated
Gødstrup Regional Hospital Herning Denmark Not Yet Recruiting
Zealand University Hospital Køge Denmark Recruiting
Odense University Hospital Odense Denmark Recruiting
Department of Emergency Medicine Helsingborg Sweden Not Yet Recruiting
Department of Emergency Medicine Linköping Sweden Not Yet Recruiting
Department of Emergency Medicine Ystad Sweden Not Yet Recruiting

More Odense University Hospital trials in Sweden

The Efficacy of PIPAC and Minimally Invasive Radical Resection in High-risk Gastric Cancer Patients. Starting soon

Other trials for the same condition

Peripheral pULSe Assessment and Arterial pRessure (PULSAR) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05931601 on ClinicalTrials.gov ↗ ← All trials in Sweden