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Early Vasopressors in Sepsis

Study acronym: EVIS
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Enrollment target: 1005 to 1006
    • Study sites: 23 to 25
    • Secondary endpoints: 15 to 17
    v6
  2. Enrollment target: 3286 to 1005v5 Show 6 more changesShow less
    • Primary completion date: Jul 2025 to Nov 2026
    • Primary endpoint revised
    • Study sites: 25 to 23
    • Study completion date: Sep 2025 to Oct 2027
    • Secondary endpoints revised (15)
    • Eligibility criteria expanded, about 1 word
  3. Study sites: 15 to 25
    • Eligibility criteria expanded, about 75 words
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 6 more changesShow less
    • Primary completion date: Jul 1, 2023 to Jul 2025
    • Start date changed from estimate of Mar 1, 2022 to Oct 11, 2022
    • Study completion date: Jul 30, 2025 to Sep 2025
    • Eligibility criteria expanded, about 117 words
    • Secondary endpoints: 13 to 15
    • Collaborators: 5 to 6
  5. Collaborators: 6 to 5v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Sepsis is a life-threatening reaction to an infection. It happens when the immune system overreacts to an infection and starts to damage the body's tissues and organs. The aim of this research study is to compare the two different ways to treat sepsis, in the early phase of treatment immediately after the participants arrive in hospital. The standard approach is to give a salt solution fluid through a drip in the participants arm to start with, then adding in a medication that increases the blood flow to the participants vital organs (a vasopressor mediation called norepinephrine) if required. The alternative approach is to start the vasopressor medication immediately, and then add in extra salt solution fluid via a drip if required. Vasopressors work by increasing the blood pressure which allows a better blood flow to the internal organs. The investigators plan to see which approach is better and to see if they have a role in improving a patient's recovery time, reducing complications, the length of time they stay in hospital and longer term poor health. Based on research that has already been done, the investigators believe treating patients with vasopressors when they arrive in the Emergency Department, may have potential advantages over the standard fluids used today. However, the evidence is not clear and that is why this research is being done.
Trial Details
NCT Number NCT05179499
Lead Sponsor NHS Greater Glasgow and Clyde
Collaborators: University of Edinburgh, Northern Care Alliance NHS Foundation Trust, University of Manchester, University of Glasgow, NHS Lothian, Chelsea and Westminster NHS Foundation Trust
Conditions
(from sponsor)		 Sepsis
Related terms Sepsis
Enrollment 1,006 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov