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Early Initiated Vasopressor Therapy in the Emergency Department

Study acronym: VASOSHOCK
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026v8 Show 4 more changesShow less
    • Study sites: 5 to 8
    • Study completion date: Jan 31, 2026 to Jan 31, 2027
    • Secondary endpoints: details revised at 1 of 4 entries
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv7
  3. Primary endpoint revised
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 41 words
    • Secondary endpoints revised (4)
    v6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 15, 2023 to Dec 8, 2023
    • Site details revised at 4 of 4 sites
    v5
  5. Start date: Nov 15, 2023 to Dec 15, 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Oct 1, 2023 to Nov 15, 2023v3
  2. Study title shortened, about 6 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05931601
Lead Sponsor Odense University Hospital
Conditions
(from sponsor)		 Shock, Shock, Septic, Hypotension, Hypotension and Shock, Hypotension Symptomatic, Hypovolemia, Hypovolemic Shock, Hypovolemic
Related terms Emergencies, Hypotension, Hypovolemia, Shock, Shock, Septic
Enrollment 320 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov