Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Critical Illness Clinical Trial

— PREVENTION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05014581
• Other study ID #: PREVENTION
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University of Turin, Italy
• Contact: Vincenzo Russotto, MD
• Phone: +393297893044
• Email: vincenzo.russotto[@]unito.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 420
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency
• Shock

Intervention

Drug:
• Noradrenaline
Pre-emptive continuous infusion of noradrenaline during the peri-intubation period

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes
Ireland	Galway University Hospitals	Galway
Italy	University Hospital San Luigi Gonzaga	Orbassano	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	Istituto Di Ricerche Farmacologiche Mario Negri

Countries where clinical trial is conducted

France,  Ireland,  Italy, 

References & Publications (3)

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 — View Citation

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, B — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with cardiac arrhythmias	Any ventricular or supraventricular arrhythmia	30 minutes from induction
Other	Number of patients with bradycardia	Heart rate < 60 beats per minute	30 minutes from induction
Other	Signs of tissue/peripheral ischemia at noradrenaline infusion site	Any sign of tissue/limb ischemia in case of peripheral vein infusion of noradrenaline	24 hours
Other	Need for new start of renal replacement therapy	Need to start either continuous or intermittent renal replacement therapy	28 days from intubation
Other	Total amount of fluid administered (ml)	Cumulative volume of fluids (ml)	30 minutes from induction
Other	First pass intubation success	Confirmed intubation after a single attempt of laryngoscopy	30 minutes from induction
Other	Total amount of rescue vasopressors after induction	Cumulative dose of any vasopressor administered either as a bolus or continuous infusion	30 minutes from induction
Other	ICU-free days	Total number of days outside the ICU up to 28 days	28 days from intubation
Other	Ventilator-free days	Total number of days free from invasive mechanical ventilation	28 days from intubation
Other	Vasopressor-free days	Total number of days free from any vasopressor administration	28 days from intubation
Other	In-hospital mortality	Death during the hospital admission up to 28 days	28 days from intubation
Primary	Number of patients with cardiovascular collapse	Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest	30 minutes from induction
Secondary	Number of patients with cardiac arrest	Development of either a shockable or non shockable rhythm associated with cardiac arrest	30 minutes from induction
Secondary	Number of patients with MAP < 60 mmHg	Mean arterial pressure < 60 mmHg	30 minutes from induction
Secondary	Need for a rescue vasopressor	Any unplanned administration of a vasopressor (either as bolus or continuous infusion)	30 minutes from induction
Secondary	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	30 minutes from induction
Secondary	Lowest value of SBP	Lowest systolic blood pressure	30 minutes from induction
Secondary	Number of patients with severe hypertension	Mean arterial pressure > 120 mmHg	30 minutes from induction