NCT06779942

The Association Between IL17, Acute Respiratory Distress Syndrome and Acute Respiratory Failure

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 414 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Respiratory Distress Syndrome (ARDS)
• Acute Respiratory Failure (ARF)

Timeline

• Start date: 2024-12-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-01-17
• Last updated: 2025-02-07

Locations

2 sites across 1 country: France