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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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

Time frame
Up to 6 months
2

Length of stay in the ICU and hospital

Time frame
Up to 6 months
3

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

Time frame
Up to 6 months
4

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

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

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