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CALLY Index, Frailty and SOFA-2 for Mortality Prediction in Geriatric ICU Patients

Prognostic Value of CALLY Index, Frailty and SOFA-2 Score for Mortality in Geriatric Intensive Care Patients: A Prospective Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07579728
Acronym
CALLY-FS
Enrollment
138
Registered
2026-05-12
Start date
2026-04-30
Completion date
2026-07-07
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Frailty, Intensive Care Unit (ICU)

Keywords

CALLY index, frailty, SOFA-2 score, ICU mortality, Geriatric patients

Brief summary

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.

Detailed description

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.

Interventions

OTHERobservational study

No intervention is applied.This is an observational study in which patients receive standart clinical care.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ICU MortalityFrom ICU admission until ICU discharge or death, assessed up to 28 daysAll-cause mortality occurring during the intensive care unit stay.

Secondary

MeasureTime frameDescription
28-day Mortality28 daysAll-cause mortality within 28 days after ICU admission.
ICU Length of StayFrom ICU admission until ICU discharge or death, assessed up to 28 daysDuration of stay in the intensive care unit, measured in days.
Hospital Length of StayFrom hospital admission until hospital discharge or death, assessed up to 28 daysTotal length of hospital stay, measured in days.
Duration of Mechanical VentilationFrom initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 daysTotal duration of invasive mechanical ventilation, measured in days.
Vasopressor RequirementFrom ICU admission until ICU discharge or death, assessed up to 28 daysRequirement for vasopressor support at any time during ICU stay.
Renal Replacement Therapy RequirementFrom ICU admission until ICU discharge or death, assessed up to 28 daysRequirement for renal replacement therapy (RRT) during ICU stay.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026