Blood Cell Count Derived Inflammatory Indexes in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Dynamic Blood Cell Count Derived Inflammatory Indexes as a Biomarker in Acute Exacerbation of Idiopathic Pulmonary Fibrosis
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.
Study Overview
Status
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial pneumonia of unknown cause carrying a median survival of approximately three years from diagnosis. While most patients experience gradual functional deterioration, a substantial subset suffers acute exacerbations (AE-IPF) characterized by rapid worsening of dyspnea, new bilateral ground-glass opacities or consolidation on imaging, and severe hypoxemia. AE-IPF carries an in-hospital mortality of 50% or higher, and clinicians currently lack reliable bedside tools to predict which patients will improve with conservative therapy and who will require early escalation.
The complete blood count (CBC) is a widely available and inexpensive laboratory test. Mathematically derived ratios and composite indices (such as the neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], platelet-to-lymphocyte ratio [PLR], and systemic immune-inflammation index [SII]) reflect the balance of innate and adaptive immunity and have been associated with adverse outcomes across various inflammatory and neoplastic conditions. However, most CBC-index work in IPF has examined stable-state prognostication or static admission values. This study addresses a substantive gap in the literature by systematically characterizing the dynamic behavior of these indices in response to AE-IPF treatment, utilizing head-to-head paired comparisons of baseline versus on-treatment change values.
This prospective, single-centre observational cohort study will be conducted at Assiut University Hospitals. Enrolled patients will undergo a full medical and clinical history, clinical examination, and a high-resolution computed tomography (HRCT) review to re-confirm the underlying usual interstitial pneumonia (UIP) pattern.
Key assessments include:
- CBC Monitoring: Assessed at days 0, 3, 7, and 14 (if hospitalized) to track absolute cell counts and calculate derived inflammatory indices (NLR, MLR, PLR, SII, SIRI, AISI, and PIV).
- Arterial Blood Gas (ABG): Assessed on stable FiO2 to track the PaO2/FiO2 ratio from day 0 to day 7.
- GAP Index: Calculated using the most recent stable-state pulmonary function values (incorporating gender, age, and physiology) whenever possible.
- Clinical Monitoring:Treatment exposures (steroids, antibiotics, antifibrotics), adverse events, and escalations to ventilatory support will be recorded.
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
- Written informed consent from the patient or legally authorized representative.
Exclusion Criteria:
- 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.
- Primary hematologic disorder altering the complete blood count, including leukemia, lymphoma, myelodysplastic syndrome, aplastic anemia, or known immune-mediated cytopenia.
- Anticipated transfer to another facility within 72 hours of admission.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Hospitalized AE-IPF Cohort
Adult patients (18 years or older) with an established diagnosis of Idiopathic Pulmonary Fibrosis (IPF) admitted to the hospital for an acute exacerbation of IPF (AE-IPF) within 72 hours of symptomatic worsening. The cohort will be observed for changes in complete blood count (CBC)-derived inflammatory indices (such as NLR, MLR, PLR, SII, SIRI, AISI, and PIV) and PaO2/FiO2 ratio over a specified interval (days 0, 3, 7, and 14). Standard treatment exposures, including steroids, antibiotics, and antifibrotics, will also be recorded. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2)
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Inflammatory Indexes in AE-IPF
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