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Clinical Trials/NCT07013032
NCT07013032
Recruiting
Not Applicable

Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Patients With Ventilator-Associated Pneumonia: A Prospective Observational Study

Konya City Hospital1 site in 1 country42 target enrollmentStarted: July 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Konya City Hospital
Enrollment
42
Locations
1
Primary Endpoint
Diagnostic accuracy of reticulated platelet fraction (RP%) in diagnosing ventilator-associated pneumonia (VAP)

Overview

Brief Summary

Ventilator-associated pneumonia (VAP) is a serious infection that occurs in patients who have been on mechanical ventilation for more than 48 hours in the intensive care unit (ICU). Early and accurate diagnosis is critical to reduce complications and improve outcomes. This prospective observational study aims to evaluate the diagnostic and prognostic value of reticulated platelet fraction (RP%) in patients diagnosed with VAP. Blood samples will be taken as part of routine care, and RP% levels will be analyzed using a standard hematology analyzer. The study will investigate whether RP% can help identify VAP earlier and predict outcomes such as mortality and response to antibiotics.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years or older
  • Receiving mechanical ventilation for more than 48 hours
  • Diagnosed with ventilator-associated pneumonia (VAP) according to clinical, radiologic, and laboratory criteria

Exclusion Criteria

  • Diagnosis of pneumonia upon ICU admission
  • Pneumonia as the primary reason for initiation of mechanical ventilation
  • Mechanical ventilation duration less than 48 hours
  • Pregnant or breastfeeding patients
  • Presence of chronic inflammatory conditions, hematologic disorders, malignancy, autoimmune disease, or immunosuppressive/chemotherapy/radiotherapy treatment within the past 4 weeks

Outcomes

Primary Outcomes

Diagnostic accuracy of reticulated platelet fraction (RP%) in diagnosing ventilator-associated pneumonia (VAP)

Time Frame: Within 48 hours of VAP diagnosis

Diagnostic performance of reticulated platelet fraction (RP%) measured as percentage (%) using the Sysmex XN-1000 hematology analyzer (from EDTA-anticoagulated whole blood). The outcome will be evaluated based on sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for VAP diagnosis, using established clinical and microbiological criteria as the reference standard.

Secondary Outcomes

  • Correlation between baseline RP% and 28-day all-cause mortality(28 days from VAP diagnosis)

Investigators

Sponsor
Konya City Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

HASAN ŞENAY

Dr. Hasan Şenay, Principal Investigator, Department of Intensive Care Medicine, Konya City Hospital TURKEY

Konya City Hospital

Study Sites (1)

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