- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Istanbul, Turquie (Türkiye)
- Başakşehir Çam and Sakura City Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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ICU Mortality
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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28-day Mortality
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KAEK/04.02.2026.82
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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