Study on Dornase Alfa and Placebo to Reduce ARDS in Ventilated Trauma Patients in ICU

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dornase alfa on patients who have experienced severe trauma. Severe trauma refers to serious injuries that can occur from accidents or other significant impacts. The study aims to see if inhaling dornase alfa can help reduce the chances of developing a condition known as acute respiratory distress syndrome (ARDS). ARDS is a serious lung condition that can happen when the lungs are severely injured, making it hard to breathe.

In this study, patients who have experienced severe trauma and are in the intensive care unit (ICU) will receive dornase alfa through inhalation. This means the medication is given as a mist that is breathed into the lungs. The study will compare the effects of dornase alfa with a placebo to see if it helps in reducing the incidence of moderate to severe ARDS during the first week after the trauma. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

The trial will take place over a period of time, with patients being monitored closely to observe any changes in their condition. The goal is to determine if early treatment with dornase alfa can effectively lower the risk of developing ARDS in patients who have suffered from severe trauma and are receiving mechanical ventilation in the ICU. This research could provide valuable insights into improving care for trauma patients and potentially preventing serious lung complications.

1 joining the study

Upon joining the study, the patient is identified as having experienced severe trauma with an Injury Severity Score greater than 15.

The patient is under mechanical ventilation for an expected duration of more than 48 hours and is admitted to the intensive care unit (ICU) within 6 hours of arrival or within 18 hours if prior surgery or embolization occurred.

A signed informed consent is obtained from the patient’s relative.

2 treatment administration

The patient receives dornase alfa or a placebo through inhalation using a nebulizer. This treatment is administered intratracheally.

The objective is to reduce the incidence of moderate to severe acute respiratory distress syndrome (ARDS) during the first 7 days post-trauma.

3 monitoring and evaluation

The patient’s condition is monitored to assess the incidence of moderate to severe ARDS, defined by a PaO2/FiO2 ratio of less than 200.

The monitoring period focuses on the first 7 days following the trauma.

4 completion of the study

The study is estimated to conclude by September 3, 2027.

The primary endpoint is the incidence of moderate to severe ARDS in patients with severe trauma.

Who Can Join the Study?

Must be an adult over 18 years old, regardless of gender, and part of the National Health Service.
Must have experienced severe trauma, which means a serious injury, with an Injury Severity Score greater than 15. This score is a way to measure how serious the injuries are.
Must be on mechanical ventilation for more than 48 hours. This means using a machine to help with breathing. If the patient is taken off the machine within the first 48 hours, they can still be part of the study.
Must have been admitted to the Intensive Care Unit (ICU) for less than 6 hours, or less than 18 hours after arriving at the hospital if they had surgery or a procedure to stop bleeding.
A relative of the patient must have signed an informed consent form, which is a document that explains the study and agrees to the patient’s participation.
Must have an indwelling arterial catheter, which is a small tube placed in an artery to monitor blood pressure and take blood samples.
If the patient is a woman of childbearing age, she must have a negative blood pregnancy test to ensure she is not pregnant.

Who Cannot Join the Study?

Patients who do not have severe trauma. Severe trauma refers to serious injuries that can affect multiple parts of the body.
Patients who are not in the age range specified for the study. The study is for certain age groups, and those outside this range cannot participate.
Patients who are not hospitalized in intensive care. Intensive care is a special department in the hospital for patients who need close monitoring and support.
Patients who do not meet the specific medical condition requirements, such as having an Injury Severity Score (ISS) greater than 15. The ISS is a medical score to assess trauma severity.
Patients who are not at risk of developing acute respiratory distress syndrome (ARDS). ARDS is a serious lung condition that makes it hard to breathe.
Patients who are not part of the vulnerable population selected for the study. Vulnerable populations may include groups like children, elderly, or those with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Ctfjdy Hihvsbfyjtx Uhwvscoaxyodh Rhfiy	Reims	France
Adcmsdnrry Pweyyhze Hddewind Dk Mddhkjuye	Marseille	France
Cypl Du Nxzrw	Vandoeuvre Les Nancy	France
Carews Hfegveojwvh Rfxcyowg Diawpjpsbztard	Angers	France
Hbxfrzyg Uuzymwmztrrpvy Srzbndukqm &ytroxo Hyduwsn dh Himokjhzudw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	04.03.2019

Trial locations

Investigated drugs:

Dornase Alfa is a medication used in this clinical trial to help reduce the incidence of moderate to severe acute respiratory distress syndrome (ARDS) in patients who have experienced severe trauma and are on ventilators in the intensive care unit. It is administered early through the trachea to help improve breathing by breaking down mucus in the lungs, which can help prevent complications associated with ARDS.

Investigated diseases:

Acute respiratory distress syndrome

Severe Trauma – Severe trauma refers to significant physical injuries that can affect multiple parts of the body, often resulting from accidents or violence. These injuries can lead to complications such as bleeding, fractures, and damage to internal organs. The body’s response to severe trauma can include inflammation and shock, which may require intensive medical care. Patients with severe trauma often need immediate and comprehensive treatment to stabilize their condition. The severity of the trauma is often assessed using the Injury Severity Score (ISS), with scores above 15 indicating severe trauma. Recovery can be complex and may involve long-term rehabilitation.

Acute Respiratory Distress Syndrome (ARDS) – Acute Respiratory Distress Syndrome is a serious lung condition that occurs when fluid builds up in the air sacs, leading to severe breathing difficulties. It often develops in people who are critically ill or have significant injuries, such as severe trauma. ARDS is characterized by rapid onset of widespread inflammation in the lungs, which can severely impair oxygen exchange. The condition can progress quickly, requiring intensive medical intervention to support breathing. ARDS is diagnosed based on specific criteria, including a low PaO2/FiO2 ratio, indicating impaired oxygenation. Management focuses on supporting lung function and addressing the underlying cause.

Trial ID:

2024-512034-14-00

Protocol code:

6998

NCT ID:

NCT03368092

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dornase Alfa and Placebo to Reduce ARDS in Ventilated Trauma Patients in ICU

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?