Blood Cell Count Derived Inflammatory Indexes in Acute Exacerbation of Idiopathic Pulmonary Fibrosis

Sponsor
Assiut University
Study ID
NCT07783230
Status
Not Yet Recruiting

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Conditions

  • Acute Exacerbation of Idiopathic Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
70 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Change in Ratio of Arterial Oxygen Partial Pressure to Fractional Inspired Oxygen (PaO2/FiO2) [ Time Frame: Baseline ]

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