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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universita Degli Studi Di Torino

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

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

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. Patient has a Critical illness (i.e. life-threatening condition requiring tracheal intubation for cardiorespiratory failure or neurological impairment).
3. Administration of sedation (with or without neuromuscular blockade) is planned
4. Written informed consent is provided by the patient and/or next-of-kin. If the patient will be unable to receive information and no next-of-kin can be contacted during screening for the trial, patient enrollment will be completed as an emergency procedure by the ICU physician, according to local national legislation.
5. Planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit

Exclusion criteria 11

1. 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. Cardiac arrest requiring tracheal intubation during cardiopulmonary resuscitation
5. Enrolled in another clinical trial that is unapproved for co-enrolment
6. Known or suspected pregnancy based upon patient information.
7. Age less than 18 years.
8. Active brain injury with clinical suspicion of elevated intracranial pressure.
9. Patient not affiliated to any health insurance system, according to local national legislation
10. Previous enrollment in the PREVENTION trial
11. Hypersensitivity to noradrenaline or to any of the excipients.

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. Incidence of cardiac arrest
2. Rate of mean arterial pressure (MAP) < 60 mmHg
3. Lowest systolic blood pressure within 30 minutes from induction
4. Rate of 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. Incidence of severe hypertension (MAP > 120 mmHg) by 30 minutes from induction

Investigational products

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

Test 1

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

Vincenzo Russotto

Public contact point

Organisation

Mario Negri Institute For Pharmacological Research IRCCS

Contact name

Vincenzo Russotto

Sponsor responsibilities

Article 77 compliance

Universita Degli Studi Di Torino

Contact point sponsor

Universita Degli Studi Di Torino

Article 77 implementation

Universita Degli Studi Di Torino

Locations

2 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 41 files

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

Application history

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