Prospective Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted for Acute Respiratory Failure

NCT06855004 | Recruiting DMC

• 1 other identifier: APHP241343
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibrosing Interstitial Lung Disease

Keywords

fibrosing interstitial lung disease; intensive care or critical care units; mortality

Outcome Measures

Primary Outcomes (1)

• Overall survival at 6 months.

  Survival will be assessed from the date of admission to intensive care (Day 0) until the date of death from any cause. Patients who are lost to follow-up or alive at the end of their follow-up period will be censored on the last date their status was documented. The maximum follow-up duration for each patient will be six months. For patients lost to follow-up before the planned follow-up period ends, their vital status (alive or deceased) will be verified with their town of birth registry.

  6 months

Secondary Outcomes (12)

• Overall survival in the intensive care unit (ICU) and hospital

  Up to 6 months

• Length of stay in the ICU and hospital

  Up to 6 months

• Percentage of patients requiring non-invasive ventilation techniques (e.g., high-flow oxygen therapy, non-invasive ventilation)

  Up to 6 months

• Percentage of patients requiring invasive ventilation techniques or extracorporeal membrane oxygenation (ECMO)

  Up to 6 months

• Percentage of patients requiring catecholamine infusion

  Up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a heterogeneous patient population requiring specialized expertise, and their prognosis in intensive care is poor without effective curative treatment. To date, there are no prospective multicenter studies in intensive care targeting this population. Additionally, there is no data on their quality of life following an intensive care stay.

You may qualify if:

• 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.

You may not qualify if:

• Patient under legal guardianship or with restricted freedom
• Patient hospitalized for psychiatric reasons or with a severe psychiatric illness causing a disability, subject to legal protection measures
• Pregnant woman
• Patient already enrolled in the study

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Avicenne APHP Réanimation médico-chirurgicale

Bobigny, 93009, France

RECRUITING

Study Officials

• Nathan EBSTEIN, Dr

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Nathan EBSTEIN, Dr

CONTACT

01 48 95 22 80; nathan.ebstein@aphp.fr

Stéphane Gaudry, Pr

CONTACT

01 48 95 22 81; stephane.gaudry@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: March 3, 2025
• Study Start: January 28, 2025
• Primary Completion (Estimated): July 28, 2030
• Study Completion (Estimated): October 28, 2030
• Last Updated: March 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)