Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

NCT05014581 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Noradrenaline

Pre-emptive continuous infusion of noradrenaline during the peri-intubation period

Sponsors & Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER
  • University of Turin, Italy

    lead OTHER

Principal Investigators

  • Vincenzo Russotto, MD · University Hospital San Luigi Gonzaga

  • John G Laffey, MD · University Hospital Galway, NUI Galway, Ireland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2026-03-31
Completion
2026-04-30

Countries

  • France
  • Ireland
  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05014581 on ClinicalTrials.gov