Fibrosing Interstitial Lung DiseasePIDREANCT06855004
Prospective Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted for Acute Respiratory Failure
An observational study of Fibrosing Interstitial Lung Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibrosing Interstitial Lung Disease
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2025to 28 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Avicenne APHP Réanimation médico-chirurgicale
Bobigny, 93009
Nathan EBSTEIN, Dr
Stéphane Gaudry, Pr, 01 48 95 22 81, stephane.gaudry@aphp.fr
About this study
Official title: Prospective Multicenter Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted to Intensive Care or Critical Care Units for Acute Respiratory Failure
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.
Read the detailed description
Fibrosing interstitial lung disease (ILD) encompasses a number of heterogeneous pathologies that share the common features of fibrotic and inflammatory lesions of the lung parenchyma, particularly in the space between the lung epithelium and endothelium. An epidemiological study carried out in France in the Seine Saint Denis département (PID93) estimates the prevalence of all PIDs combined at 97/100,000. Despite recent advances, ILD classically evolves towards chronic end-stage respiratory failure. Acute respiratory failure in the context of ILD is a common and severe complication, often necessitating intensive care for specialized ventilatory support.
The causes of acute respiratory failure in patients with ILD are varied. They include community-acquired or opportunistic infections (in patients on immunosuppressive therapy), pulmonary embolism and cardiac decompensation. Acute exacerbation of pulmonary fibrosis is a sudden worsening of respiratory function characterized by rapid-onset hypoxemia and new bilateral pulmonary infiltrates on imaging, often occurring without a clear cause. It involves acute lung injury superimposed on underlying fibrotic lung disease, typically associated with a high mortality rates at 3 months estimated at 50%, and 90% in patients requiring invasive mechanical ventilation. This complication occurs most frequently in advanced idiopathic pulmonary fibrosis (IPF), with an annual incidence of between 5% and 10%.
Current management guidelines for fibrosing interstitial lung diseases (ILDs) are primarily based on outdated, retrospective, single-center studies. The latest recommendations for idiopathic pulmonary fibrosis (IPF) (ATS 2022) suggest transferring patients to intensive care in cases of acute exacerbations when lung transplantation is planned, a reversible cause of deterioration is identified, or etiological investigations remain incomplete. However, in practice, acute respiratory failure in this context presents both clinical and ethical challenges due to the limited benefits of invasive mechanical ventilation for most patients with fibrosing ILDs.
Recent advancements have influenced patient care: the incidence of fibrosing ILDs has increased, partly due to improved diagnostic approaches; anti-fibrotic therapies have become the standard of care, slowing disease progression; and advances in protective ventilation and high-flow oxygen therapy have encouraged more active involvement from intensivists. Additionally, the development of extracorporeal membrane oxygenation (ECMO) in awake patients and super-emergency lung transplantation has expanded intensive care options for these patients.
The prognosis for patients with ILD admitted to intensive care remains poor. French studies by Gaudry et al. and Tandjaoui et al. highlight the unfavorable outcomes in approximately 100 patients, primarily with IPF and non-specific interstitial pneumonias, particularly when invasive mechanical ventilation is required. International literature provides limited guidance due to heterogeneous and often undocumented fibrosis etiologies in available retrospective single-center studies.
In summary, personalized, multidisciplinary care by expert teams is crucial for improving outcomes. The concentration of cases at specialized centers hinders the establishment of large prospective cohorts, leaving intensive care teams without robust, up-to-date data on diagnostics and treatments. To address these gaps, we aim to create a large, descriptive, prospective cohort across multiple centers and evaluate patients' quality of life six months post-intensive care using a dedicated questionnaire. These insights are essential for assessing the comprehensive benefits of intensive care stays.
- Conditions
- Fibrosing Interstitial Lung Disease
- Keywords
- fibrosing interstitial lung disease, intensive care or critical care units, mortality
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (12)
Overall survival in the intensive care unit (ICU) and hospital
Measured: Up to 6 months
Length of stay in the ICU and hospital
Measured: Up to 6 months
Percentage of patients requiring non-invasive ventilation techniques (e.g., high-flow oxygen therapy, non-invasive ventilation)
Measured: Up to 6 months
Percentage of patients requiring invasive ventilation techniques or extracorporeal membrane oxygenation (ECMO)
Measured: Up to 6 months
Percentage of patients requiring catecholamine infusion
Measured: Up to 6 months
Percentage of patients requiring renal replacement therapy
Measured: Up to 6 months
Percentage of patients urgently listed for lung transplantation and/or undergoing lung transplantation during hospitalization
Measured: Up to 6 months
Percentage of patients with at least one ICU-acquired infection
Percentage of patients with at least one ICU-acquired infection, including:
- Ventilator-associated pneumonia (defined by clinical symptoms and microbiological evidence: >10⁶ colony forming unit (CFU)/mL in tracheal aspirates, >10⁴ colony forming unit (CFU)/mL in bronchoalveolar lavage fluid, or >10³ colony forming unit (CFU)/mL in protected distal samples)
- Bacteremia (catheter-related or of unknown origin)
- Fungemia (catheter-related or of unknown origin)
- Viral infections requiring systemic antiviral treatment
Measured: Up to 6 months
Percentage and timing of decisions to limit active therapeutic interventions
Measured: Up to 6 months
Barthel Index at 6 months
Barthel Index at 6 months (assessed via phone)
Measured: Admission date (D0) and 6 months
Percentage of patients dependent on long-term oxygen therapy at 6 months
Measured: 6 months
Quality of life score (SF-36) before and after intensive care
Quality of life score (SF-36) before ICU admission and at 6 months post-ICU
Measured: Admission date (D0) and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start28 Jan 2025
- Primary completion28 Jul 2030 (estimated)
- Study completion28 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosing Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan EBSTEIN, Dr, Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855004
- Sponsor's protocol ID
- APHP241343
- Acronym
- PIDREA
- Status last verified
- Dec 2024
- First submitted
- 12 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort of Patients With Fibrosing Interstitial Lung Disease Admitted to Intensive Care or Critical Care Units for Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06855004
- Acronym / sponsor ID
- PIDREA / APHP241343
- Conditions
- Fibrosing Interstitial Lung Disease
- Keywords
- fibrosing interstitial lung disease, intensive care or critical care units, mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 28 Jul 2030 (estimated)
- Study completion
- 28 Oct 2030 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Fibrosing interstitial lung disease (ILD) encompasses a number of heterogeneous pathologies that share the common features of fibrotic and inflammatory lesions of the lung parenchyma, particularly in the space between the lung epithelium and endothelium. An epidemiological study carried out in France in the Seine Saint Denis département (PID93) estimates the prevalence of all PIDs combined at 97/100,000. Despite recent advances, ILD classically evolves towards chronic end-stage respiratory failure. Acute respiratory failure in the context of ILD is a common and severe complication, often necessitating intensive care for specialized ventilatory support.
The causes of acute respiratory failure in patients with ILD are varied. They include community-acquired or opportunistic infections (in patients on immunosuppressive therapy), pulmonary embolism and cardiac decompensation. Acute exacerbation of pulmonary fibrosis is a sudden worsening of respiratory function characterized by rapid-onset hypoxemia and new bilateral pulmonary infiltrates on imaging, often occurring without a clear cause. It involves acute lung injury superimposed on underlying fibrotic lung disease, typically associated with a high mortality rates at 3 months estimated at 50%, and 90% in patients requiring invasive mechanical ventilation. This complication occurs most frequently in advanced idiopathic pulmonary fibrosis (IPF), with an annual incidence of between 5% and 10%.
Current management guidelines for fibrosing interstitial lung diseases (ILDs) are primarily based on outdated, retrospective, single-center studies. The latest recommendations for idiopathic pulmonary fibrosis (IPF) (ATS 2022) suggest transferring patients to intensive care in cases of acute exacerbations when lung transplantation is planned, a reversible cause of deterioration is identified, or etiological investigations remain incomplete. However, in practice, acute respiratory failure in this context presents both clinical and ethical challenges due to the limited benefits of invasive mechanical ventilation for most patients with fibrosing ILDs.
Recent advancements have influenced patient care: the incidence of fibrosing ILDs has increased, partly due to improved diagnostic approaches; anti-fibrotic therapies have become the standard of care, slowing disease progression; and advances in protective ventilation and high-flow oxygen therapy have encouraged more active involvement from intensivists. Additionally, the development of extracorporeal membrane oxygenation (ECMO) in awake patients and super-emergency lung transplantation has expanded intensive care options for these patients.
The prognosis for patients with ILD admitted to intensive care remains poor. French studies by Gaudry et al. and Tandjaoui et al. highlight the unfavorable outcomes in approximately 100 patients, primarily with IPF and non-specific interstitial pneumonias, particularly when invasive mechanical ventilation is required. International literature provides limited guidance due to heterogeneous and often undocumented fibrosis etiologies in available retrospective single-center studies.
In summary, personalized, multidisciplinary care by expert teams is crucial for improving outcomes. The concentration of cases at specialized centers hinders the establishment of large prospective cohorts, leaving intensive care teams without robust, up-to-date data on diagnostics and treatments. To address these gaps, we aim to create a large, descriptive, prospective cohort across multiple centers and evaluate patients' quality of life six months post-intensive care using a dedicated questionnaire. These insights are essential for assessing the comprehensive benefits of intensive care stays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival at 6 months.
Time frame: 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.
12 secondary outcomes
Overall survival in the intensive care unit (ICU) and hospital
Time frame: Up to 6 months
Length of stay in the ICU and hospital
Time frame: Up to 6 months
Percentage of patients requiring non-invasive ventilation techniques (e.g., high-flow oxygen therapy, non-invasive ventilation)
Time frame: Up to 6 months
Percentage of patients requiring invasive ventilation techniques or extracorporeal membrane oxygenation (ECMO)
Time frame: Up to 6 months
Percentage of patients requiring catecholamine infusion
Time frame: Up to 6 months
Percentage of patients requiring renal replacement therapy
Time frame: Up to 6 months
Percentage of patients urgently listed for lung transplantation and/or undergoing lung transplantation during hospitalization
Time frame: Up to 6 months
Percentage of patients with at least one ICU-acquired infection
Time frame: Up to 6 months
Percentage and timing of decisions to limit active therapeutic interventions
Time frame: Up to 6 months
Barthel Index at 6 months
Time frame: Admission date (D0) and 6 months
Percentage of patients dependent on long-term oxygen therapy at 6 months
Time frame: 6 months
Quality of life score (SF-36) before and after intensive care
Time frame: Admission date (D0) and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan EBSTEIN, Dr study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosing Interstitial Lung Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan EBSTEIN, Dr (01 48 95 22 80, nathan.ebstein@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival at 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.