Diagnostic and Prognostic Value of Reticulated Platelet Fraction in Ventilator-Associated Pneumonia (REPLAY-VAP)

NCT07013032 | Recruiting

• 1 other identifier: KSH-RP-VAP-2025-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

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

  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.

  Within 48 hours of VAP diagnosis

Secondary Outcomes (1)

• Correlation between baseline RP% and 28-day all-cause mortality

  28 days from VAP diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically ill adult patients (aged 18 years and older) who are mechanically ventilated for more than 48 hours in the intensive care unit and diagnosed with ventilator-associated pneumonia (VAP).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Karatay, 42100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hasan Şenay, Principal Investigator, Department of Intensive Care Medicine, Konya City Hospital TURKEY

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 2, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

TU (1)