Prospective Multicenter Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted to Intensive Care or Critical Care Units for Acute Respiratory Failure

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective, multicenter study focuses on patients with fibrosing interstitial lung diseases (ILD) admitted to intensive care units (ICUs) for acute respiratory failure (ARF). ILD encompasses a group of heterogeneous disorders characterized by progressive fibrotic and inflammatory damage to the lung interstitium, often resulting in chronic respiratory failure. Acute respiratory failure in these patients is a severe and frequent complication caused by various factors, including infections, pulmonary embolism, cardiac decompensation, or acute exacerbation of fibrosis. Despite advances in treatment, ICU management of these patients remains a clinical and ethical challenge due to high mortality rates and limited evidence-based guidance. The study's primary objective is to assess 6-month survival following ICU admission for ARF in ILD patients. Secondary objectives include identifying prognostic factors for mortality, characterizing ICU and hospital mortality rates, and evaluating the use of organ support measures (e.g., oxygen therapy, invasive or non-invasive mechanical ventilation). Additionally, the study will examine the frequency of lung transplantation, acquired ICU infections, and decisions to limit or withdraw life-sustaining therapies. Importantly, this research aims to address a significant gap in current knowledge by building a large, descriptive, prospective cohort of ILD patients. A critical aspect of the study is the evaluation of patients' quality of life (QoL) six months after ICU discharge, using a dedicated questionnaire. This information will provide essential insights into the long-term benefits of ICU care for these patients, complementing survival data with QoL outcomes to better guide clinical decision-making and improve patient-centered care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Hospitalization in intensive care for acute respiratory failure

• Requirement for standard oxygen therapy with an O2 flow rate \> 6 l/min, high-flow oxygen therapy, or mechanical ventilation (non-invasive or invasive)

• Age ≥ 18 years

• Patient (male or female) with chronic interstitial lung disease (ILD)

‣ Diagnosis of chronic ILD confirmed by a multidisciplinary discussion (MDD) prior to admission to intensive care, or

⁃ Diagnosis of chronic ILD made during the intensive care stay due to the acute episode and confirmed by an expert opinion.

Locations
Other Locations
France
Hôpital Avicenne APHP Réanimation médico-chirurgicale
RECRUITING
Bobigny
Contact Information
Primary
Nathan EBSTEIN, Dr
nathan.ebstein@aphp.fr
01 48 95 22 80
Backup
Stéphane Gaudry, Pr
stephane.gaudry@aphp.fr
01 48 95 22 81
Time Frame
Start Date: 2025-01-28
Estimated Completion Date: 2030-10-28
Participants
Target number of participants: 250
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov