Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Turin, Italy
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Noradrenaline
DrugPre-emptive continuous infusion of noradrenaline during the peri-intubation period
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Pre-emptive vasopressorExperimental treatment 1 intervention
Group B: No vasopressorNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of patients with cardiovascular collapse
Composite outcome of mean arterial pressure \< 60 mmHg or cardiac arrest
Time frame
30 minutes from inductionSecondary outcomes
1
Number of patients with cardiac arrest
Development of either a shockable or non shockable rhythm associated with cardiac arrest
Time frame
30 minutes from induction2
Number of patients with MAP < 60 mmHg
Mean arterial pressure \< 60 mmHg
Time frame
30 minutes from induction3
Need for a rescue vasopressor
Any unplanned administration of a vasopressor (either as bolus or continuous infusion)
Time frame
30 minutes from induction4
Change in SBP value from last value before induction to lowest value
Drop of the systolic blood pressure from baseline value to the lowest value registered by 30 minutes from induction
Time frame
30 minutes from inductionOther outcomes
1
Number of patients with cardiac arrhythmias
Any ventricular or supraventricular arrhythmia
Time frame
30 minutes from induction2
Number of patients with bradycardia
Heart rate \< 60 beats per minute
Time frame
30 minutes from induction3
Signs of tissue/peripheral ischemia at noradrenaline infusion site
Any sign of tissue/limb ischemia in case of peripheral vein infusion of noradrenaline
Time frame
24 hours4
Need for new start of renal replacement therapy
Need to start either continuous or intermittent renal replacement therapy
Time frame
28 days from intubationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Turin, Italy
Lead sponsor
Istituto Di Ricerche Farmacologiche Mario Negri
Collaborator
Source ClinicalTrials.gov