Early Initiated Vasopressor Therapy in the Emergency Department

NCT05931601 | Recruiting Phase 3

• 2 other identifiers: OP_17492023-504584-16-00
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

Shock; Shock, Septic; Hypotension; Hypotension and Shock; Hypotension Symptomatic; Hypovolemia; Hypovolemic Shock; Hypovolemic

Keywords

Peripherally infused noradrenaline; Fluid therapy; Fluid treatment; Non-hemorrhagic shock and hypotension; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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.

  Bed-side assessment during treatment and registered in the case report form.

  At 90 minutes

Secondary Outcomes (4)

• Number of intensive care unit (ICU) free days alive within 30 days

  At 30 days

• Time without shock within 24 hours

  At 24 hours

• 30-day all-cause mortality

  At 30 days

• In-hospital all-cause mortality

  At hospital discharge, an average of 30 days efter inclusion

Other Outcomes (15)

• Proportion of patients receiving vasopressor at any point within 24 hours

  At 24 hours

• Time to vasopressor initiation

  At 30 days

• Hours of vasopressor infusion

  At 30 days

Study Arms (2)

Intervention

EXPERIMENTAL

Peripheral noradrenaline will be infused at rates of 0.05-0.15 mcg/kg/min for up to 24 hours after randomization in the ED until shock control is achieved. If shock control cannot be achieved, patients will be transferred to the ICU for further treatment of their condition but without further trial intervention. Weaning of intervention will be completed during the 24 hours, and if possible, terminated. If termination of treatment is not achievable within 24 hours, participants will be transferred to the ICU.

Drug: Noradrenaline

Control

NO INTERVENTION

No ED administered noradrenaline. Standard care of hypotension and shock in the Danish ED's are fluid therapy and if not possible to achieve shock control, they are transferred to the ICU for administration of vasopressors if they are eligible for ICU admittance.

Interventions

Noradrenaline DRUG

See arm description

Also known as: ATC-code C01CA03

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age

You may not qualify if:

• SBP \< 100mmHg or MAP \< 65 mmHg combined with lactate \> 2.0 mmol/L,
• Physician defined blood pressure for the individual patient combined with a lactate \> 2.0 mmol/L
• 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.
• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (8)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

RECRUITING

Esbjerg Hospital

Esbjerg, 6700, Denmark

TERMINATED

Gødstrup Regional Hospital

Herning, 7400, Denmark

NOT YET RECRUITING

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Department of Emergency Medicine

Helsingborg, 25223, Sweden

NOT YET RECRUITING

Department of Emergency Medicine

Linköping, 58185, Sweden

NOT YET RECRUITING

Department of Emergency Medicine

Ystad, 27133, Sweden

NOT YET RECRUITING

Related Publications (1)

• Bentsen LP, Strom T, Forberg JL, Tiwald G, Biesenbach P, Kalmriz M, Rasmussen JH, Raaber N, Moller S, Lokke M, Tygesen GB, Nygaard H, Brok JH, Andersen JW, Bajusz N, Brabrand M. 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. Scand J Trauma Resusc Emerg Med. 2025 Apr 7;33(1):59. doi: 10.1186/s13049-025-01369-4.

  PMID: 40197397 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Shock; Shock, Septic; Hypotension; Hypovolemia; Emergencies

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Vascular Diseases; Cardiovascular Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Lasse P Bentsen, MD

  Department of Emergency Medicine, Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Mikkel Brabrand, MD, PhD

  Department of Emergency Medicine, Odense University Hospital

  STUDY CHAIR

Central Study Contacts

Lasse P Bentsen, MD

CONTACT

+4520496950; lasse.paludan.bentsen@rsyd.dk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating and Principal Investigator

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 5, 2023
• Study Start: December 8, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (5); SE (3)