Using CALLY, Clinical Frailty Scale, and SOFA-2 to predict death risk in older ICU patients
Prognostic Value of CALLY Index, Frailty and SOFA-2 Score for Mortality in Geriatric Intensive Care Patients: A Prospective Cohort Study
This project will test whether the CALLY index together with frailty and SOFA-2 scores can help predict which patients aged 65 and older in the ICU are more likely to die.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT07579728 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective observational cohort of patients aged 65 and older admitted to an intensive care unit. Demographics, comorbidities, Clinical Frailty Scale, SOFA-2 and APACHE II scores, and laboratory values (CRP, albumin, lymphocyte count) will be recorded, and the CALLY index calculated within the first 24 hours. Primary outcome is ICU mortality with secondary outcomes including 28-day mortality, length of stay, duration of mechanical ventilation, vasopressor requirement, and need for renal replacement therapy. Statistical analysis will use logistic regression and ROC curve comparisons to see whether individual or combined measures improve prediction compared with conventional scoring.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 years or older admitted to the participating ICU with required clinical data and CRP, albumin, and lymphocyte results available within the first 24 hours and who are not receiving palliative care for terminal malignancy.
Not a fit: Patients who die within the first 24 hours of ICU admission, who have missing key clinical or laboratory data, or who are under terminal palliative care are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the combined use of these measures could help clinicians identify older ICU patients at higher risk of death sooner, helping guide monitoring, treatment decisions, and resource allocation.
How similar studies have performed: Frailty scores and SOFA-type scores have repeatedly been linked to mortality in older ICU populations, while the CALLY index is a newer marker with limited but growing supportive data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Istanbul
- Başakşehir Çam and Sakura City Hospital — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: TUGBA Yesilyurt Dogu, MD
- Email: tugbaayesilyurt@gmail.com
- Phone: +905535150847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.