Early Initiated Vasopressor Therapy in the Emergency Department

NCT ID: NCT05931601

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2027-01-31

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.

Detailed Description

Please refer to the full protocol.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: EXPERIMENTAL

Noradrenaline

Intervention Type: DRUG

See arm description

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Noradrenaline

See arm description

Intervention Type: DRUG

Other Intervention Names

ATC-code C01CA03

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age

Exclusion Criteria

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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lasse Paludan Bentsen, MD

Coordinating and Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lasse P Bentsen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Emergency Medicine, Odense University Hospital

Mikkel Brabrand, MD, PhD

Role: STUDY_CHAIR

Department of Emergency Medicine, Odense University Hospital

Locations

Bispebjerg Hospital

Copenhagen, , Denmark

Site Status: RECRUITING

Esbjerg Hospital

Esbjerg, , Denmark

Site Status: TERMINATED

Gødstrup Regional Hospital

Herning, , Denmark

Site Status: NOT_YET_RECRUITING

Zealand University Hospital

Køge, , Denmark

Site Status: RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status: RECRUITING

Department of Emergency Medicine

Helsingborg, , Sweden

Site Status: NOT_YET_RECRUITING

Department of Emergency Medicine

Linköping, , Sweden

Site Status: NOT_YET_RECRUITING

Department of Emergency Medicine

Ystad, , Sweden

Site Status: NOT_YET_RECRUITING

Countries

Denmark; Sweden

Central Contacts

Lasse P Bentsen, MD

Role: CONTACT

lasse.paludan.bentsen@rsyd.dk

+4520496950

Facility Contacts

Jens H. Rasmussen, MD, PhD

Role: primary

Malik Kalmriz, MD, PhD

Role: primary

Gerhard Tiwald, MD, DMSc

Role: primary

Lasse P Bentsen, MD

Role: primary

Jakob Lundager Forberg, MD

Role: primary

Daniel Wilhelms, MD

Role: primary

Rachel Keeling, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 40197397 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.kliniskforskning.dk/vasoshock/

Related Info

Other Identifiers

2023-504584-16-00

Identifier Type: CTIS

Identifier Source: secondary_id

OP_1749

Identifier Type: -

Identifier Source: org_study_id