Blood Cell Count Derived Inflammatory Indexes in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease characterized by progressive scarring. Sometimes, patients experience a sudden and severe worsening of their symptoms, known as an acute exacerbation (AE-IPF), which carries a high risk of mortality. Currently, doctors lack reliable bedside tools at the time of hospital admission to predict which patients will improve with standard care and which will require early escalation of treatment.
This prospective observational study aims to determine if simple, widely available blood tests can be used as biomarkers to predict patient outcomes during an acute exacerbation. Researchers will focus on complete blood count (CBC)-derived inflammatory indexes, which are calculated ratios of different types of blood cells (such as the neutrophil-to-lymphocyte ratio).
Participants hospitalized with AE-IPF will have their blood cell counts and oxygen levels (PaO2/FiO2 ratio) monitored on days 0 (admission), 3, 7, and 14. The study will evaluate the correlation between the change in these inflammatory indexes and the change in oxygen levels over the first week of hospitalization. Additionally, it will assess how accurately the admission blood test values, compared to the changes seen by day 3, can predict in-hospital clinical deterioration (such as the need for a ventilator, transfer to the intensive care unit, or death).
The aim is to find out if tracking changes in these simple blood test indexes can provide clinicians with a cost-effective, early-warning tool to guide treatment decisions for patients suffering from AE-IPF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older.
Established diagnosis of idiopathic pulmonary fibrosis per the 2023 ATS/ERS/JRS/ALAT clinical practice guideline, based on a multidisciplinary assessment incorporating clinical features, high-resolution computed tomography pattern, and, where available, surgical lung biopsy.
Hospital admission for acute exacerbation of IPF meeting the 2016 International Working Group criteria: previous or concurrent IPF diagnosis; acute worsening or development of dyspnea of less than one month duration; computed tomography showing new bilateral ground-glass abnormality or consolidation superimposed on a background pattern of usual interstitial pneumonia; deterioration not fully explained by cardiac failure or fluid overload and triggered exacerbations would be included.
Admission within 72 hours of symptomatic worsening.
Disqualifiers
Alternative explanation for acute respiratory deterioration confirmed at or shortly after admission, including but not limited to microbiologically confirmed bacterial pneumonia with positive blood or respiratory culture, computed-tomography-confirmed pulmonary embolism, cardiogenic pulmonary edema with elevated brain natriuretic peptide and supportive echocardiographic findings, or pneumothorax.
Interstitial lung disease attributable to a defined cause: connective-tissue-disease-associated ILD, chronic hypersensitivity pneumonitis, occupational pneumoconiosis, sarcoidosis, or drug-induced ILD.
Active solid or hematologic malignancy, including any malignancy under active treatment within the preceding 12 months.
Receipt of cytotoxic chemotherapy, radiotherapy, or non-IPF immunosuppressive therapy (excluding maintenance corticosteroid at prednisolone-equivalent $\le$ 10 mg daily) within the preceding 30 days.
Trial population
The study population consists of adult patients (18 years of age or older) with an established diagnosis of idiopathic pulmonary fibrosis (IPF) who are admitted to a tertiary referral center (Assiut University Hospitals) for an acute exacerbation of IPF within 72 hours of symptomatic worsening.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
70 Participants
are grouped into 1 trial groupGroup A: Hospitalized AE-IPF Cohort
Trial outcomes
Primary outcomes
1
Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
The PaO2/FiO2 ratio assesses hypoxemia and lung function. The outcome is the absolute change in this ratio, calculated as: (PaO2/FiO2 on day 7) - (PaO2/FiO2 on day 0). For patients who die before day 7, the worst (lowest) PaO2/FiO2 value recorded prior to death is used as the day-7 value. For patients discharged before day 7, the value on the day of discharge is carried forward.
Time frame
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: