NCT05014581 Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
| NCT ID | NCT05014581 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Turin, Italy |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2024-08-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 420 participants in total. It began in 2024-08-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patient is admitted or scheduled for admission to a participating study hospital * Planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit * Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment) * Administration of sedation (with or without neuromuscular blockade) is planned * Age 18 years or older Exclusion Criteria: * No vasopressors/inotropes at the moment of screening for eligibility * MAP \< 60 mmHg or \> 120 mmHg at the moment of screening for eligibility * Urgency of intubation precludes safe performance of study procedures * Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest * Enrolled in another clinical trial that is unapproved for co-enrollment * Pregnant or suspected pregnancy
Contact & Investigator
Vincenzo Russotto, MD
PRINCIPAL INVESTIGATOR
University Hospital San Luigi Gonzaga
Frequently Asked Questions
Who can join the NCT05014581 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05014581 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 420 participants.
Is NCT05014581 currently recruiting?
Yes, NCT05014581 is actively recruiting participants. Contact the research team at vincenzo.russotto@unito.it for enrollment information.
Where is the NCT05014581 trial being conducted?
This trial is being conducted at Nantes, France, Galway, Ireland, Rozzano, Italy, Orbassano, Italy and 2 additional locations.
Who is sponsoring the NCT05014581 clinical trial?
NCT05014581 is sponsored by University of Turin, Italy. The principal investigator is Vincenzo Russotto, MD at University Hospital San Luigi Gonzaga. The trial plans to enroll 420 participants.