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| Name | Class |
|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-emptive vasopressor | Experimental | Pre-emptive continuous infusion of norepinephrine during intubation |
|
| No vasopressor | No Intervention | No pre-emptive administration of vasopressors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noradrenaline | Drug | Pre-emptive continuous infusion of noradrenaline during the peri-intubation period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with cardiovascular collapse | Composite outcome of mean arterial pressure < 60 mmHg or cardiac arrest | 30 minutes from induction |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with cardiac arrest | Development of either a shockable or non shockable rhythm associated with cardiac arrest | 30 minutes from induction |
| Number of patients with MAP < 60 mmHg |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with cardiac arrhythmias | Any ventricular or supraventricular arrhythmia | 30 minutes from induction |
| Number of patients with bradycardia | Heart rate < 60 beats per minute |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Russotto, MD | Contact | +393297893044 | vincenzo.russotto@unito.it | |
| Antonella Vasamì | Contact | antonella.vasami@marionegri.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Russotto, MD | University Hospital San Luigi Gonzaga | Principal Investigator |
| John G Laffey, MD | University Hospital Galway, NUI Galway, Ireland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nantes | Not yet recruiting | Nantes | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33755076 | Result | 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. | |
| 31529354 |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Mean arterial pressure < 60 mmHg
| 30 minutes from induction |
| Need for a rescue vasopressor | Any unplanned administration of a vasopressor (either as bolus or continuous infusion) | 30 minutes from induction |
| 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 |
| Lowest value of SBP | Lowest systolic blood pressure | 30 minutes from induction |
| Number of patients with severe hypertension | Mean arterial pressure > 120 mmHg | 30 minutes from induction |
| 30 minutes from induction |
| 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 |
| Need for new start of renal replacement therapy | Need to start either continuous or intermittent renal replacement therapy | 28 days from intubation |
| Total amount of fluid administered (ml) | Cumulative volume of fluids (ml) | 30 minutes from induction |
| First pass intubation success | Confirmed intubation after a single attempt of laryngoscopy | 30 minutes from induction |
| Total amount of rescue vasopressors after induction | Cumulative dose of any vasopressor administered either as a bolus or continuous infusion | 30 minutes from induction |
| ICU-free days | Total number of days outside the ICU up to 28 days | 28 days from intubation |
| Ventilator-free days | Total number of days free from invasive mechanical ventilation | 28 days from intubation |
| Vasopressor-free days | Total number of days free from any vasopressor administration | 28 days from intubation |
| In-hospital mortality | Death during the hospital admission up to 28 days | 28 days from intubation |
| Galway University Hospitals | Not yet recruiting | Galway | Ireland |
|
| Humanitas Research Hospital | Recruiting | Rozzano | Milan | Italy |
|
| University Hospital San Luigi Gonzaga | Not yet recruiting | Orbassano | Turin | 10043 | Italy |
|
| ASST Grande Ospedale Metropolitano Niguarda | Recruiting | Milan | Italy |
|
| Policlinico di Milano | Recruiting | Milan | Italy |
|
| Result |
| 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. |
| 31585796 | Result | 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. |
| D012140 | Respiratory Tract Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |