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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

5 criteria

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 trial?

4 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
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Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Turin, Italy
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Azienda Provinciale Per I Servizi Sanitari
Trento, Italy

Trial locations

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Investigated drugs

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.

Noradrenaline Tartrate

What is already known about the treatment

Vasopressors – These medications are typically administered intravenously to manage critically low blood pressure, especially during medical procedures like tracheal intubation. Currently, vasopressors are well-established in medical practice and literature for their role in stabilizing blood pressure in critically ill patients. They are primarily used to prevent cardiovascular collapse by constricting blood vessels, which increases blood pressure. At the molecular level, vasopressors work by stimulating receptors in the blood vessels, leading to vasoconstriction. They are classified pharmacologically as adrenergic agonists.

Investigated diseases

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.