- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Diyarbakır
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Diyarbakır, Diyarbakır, 터키 (Türkiye)
- University of Health Sciences Gazi Yaşargil Training and Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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30-Day Mortality
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Intensive Care Unit Length of Stay
기간: 30 days
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ICU stay duration in days
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30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: selen topalel, MD, Department of Anesthesiology and Reanimation, Gazi Yaşargil Training and Research Hospital, University of Health Sciences, Diyarbakır, Türkiye
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- GYEAH-PFN-RAR-2026-05
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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