Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation. The PREVENTION Randomized Multicenter Study

Who is this study for? Patients with Critical Illness, Respiratory Failure
What treatments are being studied? Noradrenaline
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Nantes
NOT_YET_RECRUITING
Nantes
Ireland
Galway University Hospitals
NOT_YET_RECRUITING
Galway
Italy
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Policlinico di Milano
RECRUITING
Milan
University Hospital San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Vincenzo Russotto, MD
vincenzo.russotto@unito.it
+393297893044
Backup
Antonella Vasamì
antonella.vasami@marionegri.it
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2026-04
Participants
Target number of participants: 420
Treatments
Experimental: Pre-emptive vasopressor
Pre-emptive continuous infusion of norepinephrine during intubation
No_intervention: No vasopressor
No pre-emptive administration of vasopressors
Related Therapeutic Areas
Sponsors
Collaborators: Istituto Di Ricerche Farmacologiche Mario Negri
Leads: University of Turin, Italy

This content was sourced from clinicaltrials.gov