Preventing caRdiovascular collapsE with VasoprEssors duriNg Tracheal IntubatiON: The PREVENTION Randomized Controlled Trial (PREVENTION trial)

2023-503895-25-00 Protocol IRFMN-9063 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 1 Aug 2024 · Status Ongoing, recruiting · 2 EU/EEA countries · 19 sites · Protocol IRFMN-9063

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 320
Countries 2
Sites 19

criticall illness

To determine the potential for pre-emptive vasopressor therapy to reduce the rate of cardiovascular collapse (composite endpoint) among critically ill adults undergoing endotracheal intubation.

Key facts

Sponsor
Universita Degli Studi Di Torino, Mario Negri Institute For Pharmacological Research IRCCS
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
1 Aug 2024 → ongoing
Decision date (initial)
2025-03-07
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Università degli Studi di Torino

External identifiers

EU CT number
2023-503895-25-00
ClinicalTrials.gov
NCT05014581

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

To determine the potential for pre-emptive vasopressor therapy to reduce the rate of cardiovascular collapse (composite endpoint) among critically ill adults undergoing endotracheal intubation.

Conditions and MedDRA coding

criticall illness

VersionLevelCodeTermSystem organ class
20.0 PT 10077264 Critical illness 100000004867

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Planned procedure is in-hospital urgent tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
  2. Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment)
  3. Administration of sedation (with or without neuromuscular blockade) is planned
  4. Age 18 years or older

Exclusion criteria 6

  1. No vasopressors/inotropes at the moment of screening for eligibility
  2. MAP < 60 mmHg or > 120 mmHg at the moment of screening for eligibility
  3. Urgency of intubation precludes safe performance of study procedures
  4. Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest
  5. Enrolled in another clinical trial that is unapproved for co-enrolment
  6. Pregnant or suspected pregnancy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Mean arterial pressure (MAP) < 60 mmHg
  2. Cardiac arrest

Secondary endpoints 6

  1. Cardiac arrest within 30 minutes from induction
  2. Mean arterial pressure (MAP) < 60 mmHg
  3. Lowest systolic blood pressure within 30 minutes from induction
  4. Need for a rescue vasopressor
  5. Change in systolic blood pressure from last value before induction to lowest value up to 30 minutes from induction
  6. Severe hypertension (MAP > 120 mmHg) by 30 minutes from induction

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

NORADRENALINA TARTRATO MONICO 2 mg/ml Concentrato per soluzione per infusione

PRD803067 · Product

Active substance
Noradrenaline Tartrate
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
1 mg/Kg milligram(s)/kilogram
Max total dose
10 mg/kg milligram(s)/kilogram
Max treatment duration
1 Week(s)
Authorisation status
Authorised
ATC code
C01CA03 — NOREPINEPHRINE
Marketing authorisation
030799011
MA holder
MONICO S.P.A.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universita Degli Studi Di Torino

Sponsor organisation
Universita Degli Studi Di Torino
Address
Regione Gonzole 10
City
Orbassano
Postcode
10043
Country
Italy

Scientific contact point

Organisation
Mario Negri Institute For Pharmacological Research IRCCS
Contact name
Lidia Staszewsky

Public contact point

Organisation
Mario Negri Institute For Pharmacological Research IRCCS
Contact name
Lidia Staszewsky

Mario Negri Institute For Pharmacological Research IRCCS

2 Total trials 1 Recruiting 1 Ended
Academic / Non-commercial
Sponsor organisation
Mario Negri Institute For Pharmacological Research IRCCS
Address
Via Mario Negri 2
City
Milan
Postcode
20156
Country
Italy

Locations

2 EU/EEA countries · 19 investigational sites

By country

CountryMS statusPlanned subjectsSites
Ireland Ongoing, recruiting 20 4
Italy Ongoing, recruiting 300 15
Rest of world — 0 —

Investigational sites

Ireland

4 sites · Ongoing, recruiting
Tallaght University Hospital, Dublin
Dept. of Anaesthesia and Intensive Care Medicine, Tallaght, Dublin 24, Dublin
Beaumont Hospital
Dept. of Anaesthesia and Intensive Care Medicine, Beaumont Road, Beaumont, Dublin 9
Galway University Hospital
Dept. of Anaesthesia and Intensive Care Medicine, Newcastle Rd, Galway, Galway
The Mater University Hospital
Dept. of Anaesthesia and Intensive Care Medicine, Eccles St, Phibsborough, Dublin

Italy

15 sites · Ongoing, recruiting
Humanitas Research Hospital
Biomedical Sciences, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Provinciale Per I Servizi Sanitari
Biologia Cellulare, Computazionale e Integrata, Largo Medaglie D'oro 9, 38122, Trento
Fondazione IRCCS San Gerardo Dei Tintori
Emergenza e Urgenza, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Scienze dell’emergenza, anestesiologiche e della rianimazione, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Anestesia, Rianimazione ed Emergenza, Corso Bramante 88, 10126, Turin
Azienda Unita Sanitaria Locale Della Romagna
UOC Anestesia e Rianimazione, Viale Luigi Settembrini 2, 47923, Rimini
ASST Grande Ospedale Metropolitano Niguarda
Anestesia e Rianimazione 1, Piazza Dell'ospedale Maggiore 3, 20162, Milan
IRCCS Ospedale Policlinico San Martino
Anestesia e Rianimazione, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Sanitaria Universitaria Friuli Centrale
Emergenza, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliera Universitaria Integrata Verona
Dipartimento: SCIENZE CHIRURGICHE, ODONTOSTOMATOLOGICHE E MATERNO-INFANTILI, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Anestesia e Rianimazione, Regione Gonzole 10, 10043, Orbassano
Universita' Degli Studi Di Ferrara
Medicina traslazionale, Via Aldo Moro 8, 44124, Ferrara
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Anestesia, Terapia Intensiva e Emergenza, Via Francesco Sforza 28, 20122, Milan
ASST Ovest Milanese - Ospedale Vecchio di Legnano
Dept. of Anaesthesia and Intensive Care Medicine, via Papa Giovanni Paolo II, 20025, Legnano
A.O.SS Antonio Biagio e Cesare Arrigo Alessandria
Dept. of Anaesthesia and Intensive Care Medicine, Via Venezia, 16 - 15121, Alessandria

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Ireland 2025-09-16 2025-09-16
Italy 2024-08-01 2024-08-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements 1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_CLEAN_ 1.1
Recruitment arrangements (for publication) K1_ Recruitment arrangements_TRACKED 1.1
Subject information and informed consent form (for publication) L1_ SIS and ICF Adults 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Adults 1 1
Subject information and informed consent form (for publication) L1_ SIS and ICF Adults 2 1
Subject information and informed consent form (for publication) L2_ Other subject information material MMG 1
Subject information and informed consent form (for publication) PREVENTION Assent to continue and Information_CLEAN_def 1.1
Subject information and informed consent form (for publication) PREVENTION Assent to continue and Information_NEW 1.0
Subject information and informed consent form (for publication) PREVENTION Assent to continue and Information_TRACKED_def 1.1
Subject information and informed consent form (for publication) PREVENTION Assent To Continue Form_REDLINED 1.1
Subject information and informed consent form (for publication) PREVENTION PIL and Consent to Continue Form_REDLINED 1.2
Subject information and informed consent form (for publication) PREVENTION PIL and CONSENT to Continue_CLEAN 1.1
Subject information and informed consent form (for publication) PREVENTION PIL and CONSENT to Continue_CLEAN_def 1.2
Subject information and informed consent form (for publication) PREVENTION PIL and CONSENT to Continue_TRACKED 1.1
Subject information and informed consent form (for publication) PREVENTION PIL and CONSENT to Continue_TRACKED_def 1.2

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-02-27 Italy Acceptable
2023-06-19
 2024-03-06
2 SUBSTANTIAL MODIFICATION SM-1 2025-04-07 Italy Acceptable 2025-05-20
3 NON SUBSTANTIAL MODIFICATION NSM-1 2025-09-04 Acceptable 2025-09-04