- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07579728
CALLY Index, Frailty and SOFA-2 for Mortality Prediction in Geriatric ICU Patients (CALLY-FS)
Prognostic Value of CALLY Index, Frailty and SOFA-2 Score for Mortality in Geriatric Intensive Care Patients: A Prospective Cohort Study
This study aims to evaluate the prognostic value of the C-reactive protein-albumin-lymphocyte (CALLY) index, Clinical Frailty Scale (CFS), and SOFA-2 score in predicting mortality among geriatric intensive care unit (ICU) patients.
The primary outcome is ICU mortality. Secondary outcomes include 28-day mortality, ICU length of stay, duration of mechanical ventilation, need for renal replacement therapy, and vasopressor requirement.
The study also investigates whether the combined use of these parameters improves predictive performance compared to conventional scoring systems such as APACHE II.
연구 개요
상세 설명
This is a single-center, prospective observational cohort study including patients aged ≥65 years admitted to the intensive care unit.
Demographic characteristics, comorbidities, frailty status (Clinical Frailty Scale), and severity scores (SOFA-2, APACHE II) will be recorded. Laboratory parameters including C-reactive protein, albumin, and lymphocyte count will be used to calculate the CALLY index within the first 24 hours of ICU admission.
Patients will be followed for ICU mortality and 28-day mortality. Additional outcomes include ICU and hospital length of stay, duration of mechanical ventilation, vasopressor requirement, and need for renal replacement therapy.
Statistical analyses will include logistic regression and receiver operating characteristic (ROC) curve analysis to evaluate the predictive performance of each parameter and their combined use.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: TUGBA Yesilyurt Dogu, MD
- 전화번호: +905535150847
- 이메일: tugbaayesilyurt@gmail.com
연구 장소
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Istanbul, 터키 (Türkiye)
- 모병
- Basaksehir Cam and Sakura City Hospital
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연락하다:
- Tugbe Yesilyurt Dogu, MD
- 전화번호: +905535150847
- 이메일: tugbaayesilyurt@gmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Age ≥65 years
- Admission to the intensive care unit
- Availability of required clinical and laboratory data within the first 24 hours of ICU admission
Exclusion Criteria:
- Death within the first 24 hours after ICU admission
- Missing key clinical or laboratory data
- Terminal malignancy receiving palliative care
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Geriatric ICU patients
Geriatric patients (aged ≥65 years) admitted to the intensive care unit will be included as a single observational cohort.
All participants will be evaluated for CALLY index, frailty status, and SOFA-2 score within the first 24 hours of ICU admission.
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No intervention is applied.This is an observational study in which patients receive standart clinical care.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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ICU Mortality
기간: From ICU admission until ICU discharge or death, assessed up to 28 days
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All-cause mortality occurring during the intensive care unit stay.
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From ICU admission until ICU discharge or death, assessed up to 28 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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28-day Mortality
기간: 28 days
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All-cause mortality within 28 days after ICU admission.
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28 days
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ICU Length of Stay
기간: From ICU admission until ICU discharge or death, assessed up to 28 days
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Duration of stay in the intensive care unit, measured in days.
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From ICU admission until ICU discharge or death, assessed up to 28 days
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Hospital Length of Stay
기간: From hospital admission until hospital discharge or death, assessed up to 28 days
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Total length of hospital stay, measured in days.
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From hospital admission until hospital discharge or death, assessed up to 28 days
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Duration of Mechanical Ventilation
기간: From initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 days
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Total duration of invasive mechanical ventilation, measured in days.
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From initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 days
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Vasopressor Requirement
기간: From ICU admission until ICU discharge or death, assessed up to 28 days
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Requirement for vasopressor support at any time during ICU stay.
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From ICU admission until ICU discharge or death, assessed up to 28 days
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Renal Replacement Therapy Requirement
기간: From ICU admission until ICU discharge or death, assessed up to 28 days
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Requirement for renal replacement therapy (RRT) during ICU stay.
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From ICU admission until ICU discharge or death, assessed up to 28 days
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공동 작업자 및 조사자
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
기타 연구 ID 번호
- KAEK/04.02.2026.82
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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