- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07607886
Inflammatory Indices, Early Mortality, and ICU Stay in Geriatric PFN Patients (PFN-RAR)
Association of Preoperative and Postoperative Inflammatory Indices With 30-Day Mortality and Intensive Care Unit Length of Stay in Geriatric Patients Undergoing Proximal Femoral Nailing: A Retrospective Observational Cohort Study
Studieoversigt
Status
Detaljeret beskrivelse
Hip fractures are associated with substantial morbidity and mortality in the geriatric population. Intertrochanteric femur fractures, in particular, frequently require surgical stabilization with proximal femoral nailing (PFN). Despite advances in perioperative care, early postoperative mortality rates and intensive care utilization remain high in elderly patients undergoing PFN surgery. Identifying reliable biomarkers that reflect the acute systemic inflammatory response to surgical trauma may improve perioperative risk stratification and postoperative management.
In recent years, several hematologic inflammatory indices derived from routine laboratory parameters have emerged as potential prognostic markers in different clinical settings. These include neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), aggregate index of systemic inflammation (AIS), immune-inflammatory prognostic index (IPI), and red cell distribution width-to-albumin ratio (RAR). However, data regarding the prognostic significance of these inflammatory indices in geriatric orthopedic trauma patients remain limited.
This retrospective observational cohort study evaluates the association between preoperative and postoperative inflammatory indices and early postoperative outcomes in geriatric patients undergoing PFN surgery for intertrochanteric femur fractures. Electronic medical records of eligible patients aged 65 years and older will be reviewed retrospectively. Demographic characteristics, comorbidities, perioperative laboratory findings, inflammatory indices, 30-day mortality, and intensive care unit (ICU) length of stay will be analyzed.
The primary outcome of the study is 30-day mortality. The secondary outcome is ICU length of stay. The study aims to determine whether inflammatory indices, particularly RDW-to-albumin ratio (RAR), are independently associated with early mortality and prolonged ICU stay in the acute postoperative period. The findings may contribute to the identification of simple and cost-effective biomarkers for early risk assessment in geriatric hip fracture patients.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
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Diyarbakır
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Diyarbakır, Diyarbakır, Tyrkiet (Türkiye)
- University of Health Sciences Gazi Yaşargil Training and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients aged 65 years and older
- Diagnosis of intertrochanteric femur fracture
- Undergoing proximal femoral nailing (PFN) surgery
- Availability of preoperative laboratory data
- Availability of early postoperative laboratory measurements
- Availability of 30-day mortality data
- Availability of intensive care unit admission and ICU length of stay data
- Complete electronic medical records
Exclusion Criteria:
- Patients with missing clinical or laboratory data
- Pathological fractures
- Multiple trauma patients
- Revision surgeries
- Presence of active infection or sepsis before surgery
- Hematologic diseases that could affect inflammatory indices
- Unavailable 30-day mortality or ICU data
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Geriatric PFN Cohort
Geriatric patients aged 65 years and older who underwent proximal femoral nailing (PFN) surgery for intertrochanteric femur fractures and were retrospectively evaluated for inflammatory indices, 30-day mortality, and intensive care unit length of stay.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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30-Day Mortality
Tidsramme: Within 30 days after surgery
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Evaluation of all-cause mortality occurring within the first 30 postoperative days in geriatric patients undergoing proximal femoral nailing surgery.
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Within 30 days after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Intensive Care Unit Length of Stay
Tidsramme: 30 days
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ICU stay duration in days
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30 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: selen topalel, MD, Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- GYEAH-PFN-RAR-2026-05
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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