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NCT Number: NCT05931601

Early Initiated Vasopressor Therapy in the Emergency Department

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.

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Key information

Conditions

Shock Cardiovascular Diseases Disease Attributes Emergencies Hypotension Hypotension Symptomatic Hypotension and Shock Hypovolemia Hypovolemic Hypovolemic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock, Septic Systemic Inflammatory Response Syndrome Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bispebjerg Hospital, Copenhagen, Denmark

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About this study

Please refer to the full protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.

Treatment and study plan

Noradrenaline

Drug

See arm description

Other names: ATC-code C01CA03

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.

    Time frame: At 90 minutes

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

Secondary outcomes

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

    Time frame: At 30 days

    Data is extracted from the Danish national registries or the patient's electronic medical record.

    Note: Death will count as 0 days.

  2. Time without shock within 24 hours

    Time frame: At 24 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  3. 30-day all-cause mortality

    Time frame: At 30 days

    Data is extracted from the Danish national registries or the patient's electronic medical records.

  4. In-hospital all-cause mortality

    Time frame: At hospital discharge, an average of 30 days efter inclusion

    Data is extracted from the Danish national registries or the patient's electronic medical records.

Other outcomes

  1. Proportion of patients receiving vasopressor at any point within 24 hours

    Time frame: At 24 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  2. Time to vasopressor initiation

    Time frame: At 30 days

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  3. Hours of vasopressor infusion

    Time frame: At 30 days

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  4. Proportion of patients with pulmonary oedema within 72 hours

    Time frame: At 72 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  5. Proportion of patients with acute kidney failure within 72 hours

    Time frame: At 72 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  6. Number of organ support free days alive within 30 days

    Time frame: At 30 days

    Organ support is defined as either mechanical ventilation, vasopressor/inotrope therapy or dialsysis.

    Data is extracted from the Danish national registries or the patient's electronic medical record.

  7. Number of organ support free days alive within 30 days

    Time frame: At 30 days

    Organ support is defined as either mechanical ventilation, vasopressor/intotropic therapy or dialysis.

    Note: Death will count as 0 days.

    Data is extracted from the Danish national registries or the patient's electronic medical record.

  8. Proportion of patients admitted to the ICU

    Time frame: At 30 days

    Data is extracted from the patient's electronic medical records.

  9. ED Length of stay

    Time frame: At 72 hours

    Data is extracted from the patient's electronic medical records.

  10. ICU length of stay

    Time frame: At 30 days

    Data is extracted from the patient's electronic medical records.

  11. Hospital length of stay

    Time frame: At 30 days

    Data is extracted from the patient's electronic medical records.

  12. Proportion and duration of mechanical ventilation

    Time frame: At 30 days

    Data is extracted from the patient's electronic medical records.

  13. Proportion and length of renal replacement therapy

    Time frame: At 30 days

    Data is extracted from the patient's electronic medical records.

  14. Amount of fluid therapy within the first 24 hours

    Time frame: At 24 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

  15. Proportion of serious adverse events for noradrenaline or fluid therapy, e.g. extravasation or overdosis of noradrenaline, pulmonary edema, new cardiac arrhytmias, during the intervention of control period

    Time frame: At 24 hours

    Bed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

Study contacts

Contact information is provided by the study sponsor or research team.

Lasse P Bentsen, MD

CONTACT

[email protected]

+4520496950

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: VASOSHOCK

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 5, 2023
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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