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Critical IllnessPhase 3PREVENTIONNCT05014581

Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

A Phase 3 study testing Noradrenaline in people with Critical Illness and Respiratory Failure, run by University of Turin, Italy at 6 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Critical Illness, Respiratory Failure
What is being tested?
Noradrenaline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
6 sitesin 3 countries
Study dates
1 Aug 2024to Apr 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Vincenzo Russotto, MD contact

+393297893044

vincenzo.russotto@unito.it

Antonella Vasamì contact

antonella.vasami@marionegri.it

6 sites in 3 countries

Italy4 sites, 4 recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Thomas Langer

    Recruiting

  • Policlinico di Milano

    Milan

    Giacomo Grasselli

    Recruiting

  • University Hospital San Luigi Gonzaga

    Orbassano, Turin, 10043

    Vincenzo Russotto, MD, vincenzo.russotto@unito.it

    Pietro Caironi, MD

    Not yet recruiting

  • Humanitas Research Hospital

    Rozzano, Milan

    Alessandro Protti

    Recruiting

Other trials in Italy

France1 site, 1 recruiting

  • CHU de Nantes

    Nantes

    Jean Baptiste Lascarrou, MD, PhD

    Not yet recruiting

Other trials in France

Ireland1 site, 1 recruiting

  • Galway University Hospitals

    Galway

    John G Laffey, MD

    Not yet recruiting

Other trials in Ireland

About this study

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

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.

Read the detailed description

PREVENTION trial is a pragmatic, multi-center, un-blinded, parallel group, randomized study comparing the pre-emptive use of noradrenaline to no-vasopressors during the peri-intubation period of adult critically ill patients. Investigators hypothesize that the pre-emptive administration of noradrenaline would mitigate the incidence and severity of peri-intubation cardiovascular collapse. The study will include adult (18 yrs or older) critically ill patients needing in-hospital intubation, excluding patients with absolute indication or contraindication to vasopressors. Patients will be randomized to receive either a continuous infusion of noradrenaline started at least 8 minutes before induction vs no vasopressors during the peri-intubation period. All co-interventions will be provided according to clinician's judgement. The primary outcome of the study will be a composite of MAP < 60 mmHg or cardiac arrest. Secondary outcomes will include lowest systolic blood pressure < 30 minutes from induction, change in systolic blood pressure from baseline to the lowest value within 30 minutes from induction and cardiac arrest.

Being tested
Noradrenaline
Keywords
tracheal intubation
Medical subject headings
Critical Illness, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NoradrenalineDrug

    Also called Norepinephrine

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

Study groups in NCT05014581
Study groupRoleWhat they receive
Pre-emptive vasopressorExperimentalPre-emptive continuous infusion of norepinephrine during intubation
Receives: Drug: Noradrenaline
No vasopressorNo interventionNo pre-emptive administration of vasopressors

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with cardiovascular collapse

    Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest

    Measured: 30 minutes from induction

Secondary outcomes (6)

  1. Number of patients with cardiac arrest

    Development of either a shockable or non shockable rhythm associated with cardiac arrest

    Measured: 30 minutes from induction

  2. Number of patients with MAP < 60 mmHg

    Mean arterial pressure < 60 mmHg

    Measured: 30 minutes from induction

  3. Need for a rescue vasopressor

    Any unplanned administration of a vasopressor (either as bolus or continuous infusion)

    Measured: 30 minutes from induction

  4. 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

    Measured: 30 minutes from induction

  5. Lowest value of SBP

    Lowest systolic blood pressure

    Measured: 30 minutes from induction

  6. Number of patients with severe hypertension

    Mean arterial pressure > 120 mmHg

    Measured: 30 minutes from induction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start1 Aug 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionApr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014581
Sponsor's protocol ID
PREVENTION
Acronym
PREVENTION
Status last verified
Mar 2025
First submitted
10 Aug 2021
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Russotto V, Myatra SN, Laffey JG, Tassistro E, Antolini L, Bauer P, Lascarrou JB, Szuldrzynski K, Camporota L, Pelosi P, Sorbello M, Higgs A, Greif R, Putensen C, Agvald-Ohman C, Chalkias A, Bokums K, Brewster D, Rossi E, Fumagalli R, Pesenti A, Foti G, Bellani G; INTUBE Study Investigators. Intubation Practices and Adverse Peri-intubation Events in Critically Ill Patients From 29 Countries. JAMA. 2021 Mar 23;325(12):1164-1172. doi: 10.1001/jama.2021.1727.

    PubMed 33755076

  • Russotto V, Myatra SN, Laffey JG. What's new in airway management of the critically ill. Intensive Care Med. 2019 Nov;45(11):1615-1618. doi: 10.1007/s00134-019-05757-0. Epub 2019 Sep 16. No abstract available.

    PubMed 31529354

  • Janz DR, Casey JD, Semler MW, Russell DW, Dargin J, Vonderhaar DJ, Dischert KM, West JR, Stempek S, Wozniak J, Caputo N, Heideman BE, Zouk AN, Gulati S, Stigler WS, Bentov I, Joffe AM, Rice TW; PrePARE Investigators; Pragmatic Critical Care Research Group. Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial. Lancet Respir Med. 2019 Dec;7(12):1039-1047. doi: 10.1016/S2213-2600(19)30246-2. Epub 2019 Oct 1.

    PubMed 31585796

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Noradrenaline in people with Critical Illness and Respiratory Failure, run by University of Turin, Italy at 6 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, France, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Vincenzo Russotto, MD (+393297893044, vincenzo.russotto@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with cardiovascular collapse (time frame: 30 minutes from induction). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05014581, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.

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