Clinical trial NCT06779942: The Association Between IL17, Acute Respiratory Distress Syndrome and Acute Respiratory Failure
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Failure (ARF)
Keywords: Acute respiratory distress syndrome (ARDS)
Acute Respiratory Failure (ARF)
IL-17 Inhibitor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Using the data from FROG ICU registry, we will create two cohorts of patients using diagnosis codes:

Acute Respiratory Distress Syndrome (ARDS) Acute Respiratory Failure (ARF) The FROG ICU registry is a completed, prospective, observational, multicenter cohort study, designed to assess the incidence and to identify the risk factors of all-cause mortality during the year following discharge from the ICU. Our study will retrospectively analyze this prospectively collected data.

The evaluation of each patient is performed through a comprehensive clinical assessment, instrumental tests (electrocardiogram, echocardiogram) and biological parameters. All the data are collected at admission, during the stay as well as at discharge and in addition these patients are followed up for long-term outcomes after ICU discharge. This allows us to evaluate the effect of different biomarkers as well as level of care in the ICU on long-term outcomes.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: ICU Mortality
timeFrame: Baseline to ICU discharge (at least 24h) or death
measure: 30 Day Mortality
timeFrame: Baseline to 30 days after ICU admission or death
measure: 60 Day Mortality
timeFrame: Baseline to 60 days after ICU admission or death
measure: Ventilator free survival
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
measure: Number of days on mechanical ventilator
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
Secondary outcomes:
measure: Hyperinflammatory ARDS subtype correlation
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
measure: Biomarker Correlation with IL-17A
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
measure: Comparison of associated biomarkers in hypo-inflammatory phenotype of ARDS
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
measure: Comparison of associated biomarkers in hyper and hypo-inflammatory phenotypes of Acute Respiratory Failure (ARF)
timeFrame: From baseline to ICU discharge, but at least for 24 hrs
Other outcomes:
Locations:
city: Paris Cedex 10
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: University Paris Diderot
Study officials:
References: