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Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Study acronym: PREVENTION
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 28, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Nov 2024 to Mar 2026
    • Start date changed from estimate of Jan 2024 to Aug 1, 2024
    • Study sites: 3 to 6
    • Study completion date: Dec 2024 to Apr 2026
  2. Start date: Apr 2023 to Jan 2024v3
  3. Lead sponsor: Azienda Ospedaliera San Gerardo di Monza to University of Turin, Italyv2 Show 8 more changesShow less
    • Primary completion date: Nov 2023 to Nov 2024
    • Start date: Nov 2021 to Apr 2023
    • Study completion date: Dec 2023 to Dec 2024
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 27 to 6
    • Study sites revised (3)
    • Collaborators expanded, about 6 words
    • Study description shortened, about 4 words
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.
Trial Details
NCT Number NCT05014581
Lead Sponsor University of Turin, Italy
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri
Conditions
(from sponsor)		 Critical Illness, Respiratory Failure
Related terms Critical Illness, Respiratory Insufficiency
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov