Study on Preventing Cardiovascular Collapse in Critically Ill Adults Using Noradrenaline Tartrate During Tracheal Intubation

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What is this study about?

This clinical trial is focused on patients with critical illness, which refers to life-threatening conditions that require urgent medical attention. The study is investigating the use of a medication called Noradrenaline Tartrate, which is administered as a solution through an intravenous infusion. This medication is being tested to see if it can help prevent cardiovascular collapse, a serious condition where the heart and blood vessels fail to function properly, during a procedure known as tracheal intubation. Tracheal intubation is a medical procedure where a tube is inserted into the windpipe to help a person breathe.

The purpose of the study is to determine if using Noradrenaline Tartrate before the intubation procedure can reduce the risk of cardiovascular collapse in critically ill adults. Participants in the study will receive either the medication or a placebo before undergoing tracheal intubation. The study will monitor the participants’ blood pressure and heart function during and after the procedure to assess the effectiveness of the treatment.

The trial aims to provide valuable information on whether pre-emptive treatment with Noradrenaline Tartrate can improve outcomes for patients undergoing tracheal intubation due to critical illness. The study is expected to continue until October 2024, with the goal of enhancing the safety and effectiveness of medical procedures for critically ill patients.

1 joining the trial

Participation begins after meeting specific criteria: being 18 years or older, having a critical illness requiring urgent tracheal intubation, and planning to receive sedation.

The procedure is performed by a qualified provider in a hospital setting.

2 medication administration

The medication used is noradrenaline tartrate, administered as a solution for infusion.

This medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

3 monitoring and assessment

The primary goal is to prevent cardiovascular collapse during the intubation process.

Monitoring includes checking the mean arterial pressure (MAP) to ensure it does not fall below 60 mmHg and observing for any signs of cardiac arrest.

4 follow-up and evaluation

Secondary assessments involve monitoring for cardiac arrest within 30 minutes of induction, changes in blood pressure, and the need for additional vasopressor support.

The evaluation also includes checking for severe hypertension, defined as MAP greater than 120 mmHg, within 30 minutes of induction.

Who Can Join the Study?

The patient must be scheduled for an urgent procedure called tracheal intubation in the hospital. This is when a tube is placed into the windpipe to help with breathing.
The person performing the intubation should be someone who regularly does this procedure in the hospital unit.
The patient must have a critical illness, which means a life-threatening condition that requires intubation because of problems with the heart and lungs or the brain.
The patient should be planned to receive sedation, which is medicine to help them relax or sleep during the procedure. This may be with or without additional medicine to relax the muscles.
The patient must be 18 years old or older.

Who Cannot Join the Study?

Patients who are not critically ill cannot participate.
Patients who are not adults cannot participate. This means the study is only for people who are 18 years or older.
Patients who are not undergoing endotracheal intubation cannot participate. This is a medical procedure where a tube is placed into the windpipe to help with breathing.
Patients who are not at risk of cardiovascular collapse cannot participate. This is a serious condition where the heart and blood vessels stop working properly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	Italy
Azienda Unita Sanitaria Locale Della Romagna	Rimini	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
University Hospital Galway	Galway	Ireland
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Socio Sanitaria Territoriale Ovest Milanese	Legnano	Italy
Beaumont Hospital	Dublin	Ireland
Anfbns Airmkvy Bplpuh e Ciazsq Avowwj Atkeatypbmz	Alexandria	Italy
Avcejng Ozxtlhohjbj Utrmsdgslemql Cjgzjqabklqi Dncxf Swvqws E Ddfhg Snmzqvq Do Tyinta	Turin	Italy

Trial status

Country	Status	Recruitment Start
Ireland	Recruiting	01.07.2023
Italy	Recruiting	01.07.2023

Trial locations

Investigated drugs:

Noradrenaline Tartrate

Vasopressors are medications used to increase blood pressure in patients who are critically ill. In this trial, they are being studied to see if giving them before a procedure called tracheal intubation can help prevent a serious drop in blood pressure, known as cardiovascular collapse.

Critical Illness – Critical illness refers to a severe health condition that poses an immediate threat to a person’s life, often requiring intensive medical care. It can result from various causes, such as severe infections, trauma, or organ failure. Patients with critical illness may experience significant physiological instability, including issues with breathing, circulation, and organ function. The progression of critical illness can be rapid, necessitating prompt medical intervention to stabilize the patient. It often involves complex interactions between different body systems, leading to challenges in maintaining normal bodily functions. The condition requires continuous monitoring and support in an intensive care setting to manage the acute health crisis effectively.

Trial ID:

2023-503895-25-00

Protocol code:

IRFMN-9063

NCT ID:

NCT05014581

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Cardiovascular Collapse in Critically Ill Adults Using Noradrenaline Tartrate During Tracheal Intubation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?