check_circleStudy Completed

Acute respiratory distress syndrome (ARDS), Acute Respiratory Failure (ARF)

Bayer Identifier:

22920

ClinicalTrials.gov Identifier:

NCT06779942

EudraCT Number:

Not Available

EU CT Number:

Not Available
The association between IL17, Acute respiratory distress syndrome and Acute Respiratory Failure

Trial purpose

This study will look at a protein called Interleukin (IL)-17A and how it relates to health markers in patients with a serious lung condition known as Acute Respiratory Distress Syndrome (ARDS). IL-17A is part of the immune system and helps the body fight infections, but too much of it can lead to inflammation, which can be harmful.

The researchers want to find out if the levels of IL-17A in the blood are connected to important health outcomes for patients, such as whether they survive in the Intensive Care Unit (ICU), after 30 days, and after 60 days. They will also check how long patients can stay off a ventilator and how many days they need to use a mechanical ventilator. A ventilator is a machine that helps people breathe when their lungs are not working well.

In addition to the main goal, the researchers will study how IL-17A relates to a severe form of ARDS called the hyperinflammatory sub-phenotype. They will also look at how IL-17A connects with other health markers, including IL-6, soluble tumor necrosis factor receptor (sTNFR), IL8, Tumor Necrosis Factor (TNF)a, IL1beta, and IL23. These markers can give information about inflammation and how the body is responding to illness.

To compare results, the researchers will include a control group of patients who had Acute Respiratory Failure (ARF) but did not have ARDS. This control group will help them understand the differences between the two conditions.

This research will use data from the FROG-ICU Registry, which gathers information on patients in intensive care units across Europe. The registry tracks patients' health after they leave the ICU, focusing on the risk factors for death in the year following their discharge. The data comes from 28 different ICUs in 19 hospitals.

The researchers will create two groups of patients based on their diagnoses: one group with ARDS and another with ARF. By studying these groups, they hope to learn more about the role of IL-17A in ARDS and its potential impact on patient outcomes.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - invasive mechanical ventilation support for at least 24 h and/or treatment with a positive inotropic agent (except dopamine) for more than 24 h
    - ARDS patients:
    o Diagnosis of ARDS at the time of study inclusion and within 24-48 hours of bio sample collection

    - ARF patients
    o Diagnosis of Acute respiratory Failure (ARF) who do not have sepsis at the time of study inclusion and within 24-48 hours of bio sample collection

  • o Patients with ARF who later develop ARDS after the 24-48 hour bio sample draw time period will be excluded as they will not have had baseline bio samples drawn in relation to onset of ARDS.

    - Patients less than 18 years old
    - severe head injury (initial Glasgow Coma Scale < 8) or brain death or a persistent vegetative state
    - pregnancy or breastfeeding
    - transplantation in the past 12 months; not expected to survive or to leave the hospital
    - no social security coverage

Trial summary

Enrollment Goal
414
Trial Dates
December 2024 - December 2024
Phase
N/A
Could I Receive a placebo
N/A
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
University Paris DiderotParis, France
Active, not recruiting
Hôpital Saint LouisParis Cedex 10, 75475, France

Primary Outcome

  • ICU Mortality
    Evaluate the association between Interleukin (IL)-17A level and mortality at the Intensive Care Unit (ICU) in patients with ARDS
    date_rangeTime Frame:
    Baseline to ICU discharge (at least 24h) or death
  • 30 Day Mortality
    Evaluate the association between IL-17A level and 30 Day mortality in patients with ARDS
    date_rangeTime Frame:
    Baseline to 30 days after ICU admission or death
  • 60 Day Mortality
    Evaluate the association between IL-17A level and 60 Day mortality in patients with ARDS
    date_rangeTime Frame:
    Baseline to 60 days after ICU admission or death
  • Ventilator free survival
    Evaluate the association between IL-17A level and ventilator free survival in patients with ARDS
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs
  • Number of days on mechanical ventilator
    Evaluate the association between IL-17A level and days on mechanical ventilator in patients with ARDS
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs

Secondary Outcome

  • Hyperinflammatory ARDS subtype correlation
    Evaluate the association between IL-17A and hyperinflammatory sub-phenotype of ARDS
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs
  • Biomarker Correlation with IL-17A
    Evaluate the correlation between IL-17A and multiple biomarkers including IL-6, sTNFR, IL8, Tumour Necrosis Factor (TNF)a, IL1beta, IL23 in patients with ARDS
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs
  • Comparison of associated biomarkers in hypo-inflammatory phenotype of ARDS
    Compare these associations with the association with these biomarkers in hypo-inflammatory phenotype of ARDS
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs
  • Comparison of associated biomarkers in hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
    Compare these associations with the association with these biomarkers in the hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
    date_rangeTime Frame:
    From baseline to ICU discharge, but at least for 24 hrs

Trial design

FROG-ARDS: Correlation of IL-17A to hyperinflammatory biomarkers, sub-phenotype, and clinical outcomes in patients with acute respiratory distress syndrome in the FROG ICU dataset
Trial Type
Observational
Intervention Type
N/A
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information