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Completed

NCT Number: NCT07579728

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Frailty Intensive Care Unit (ICU) Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

observational study

Other

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

Primary outcomes

  1. ICU Mortality

    Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days

    All-cause mortality occurring during the intensive care unit stay.

Secondary outcomes

  1. 28-day Mortality

    Time frame: 28 days

    All-cause mortality within 28 days after ICU admission.

  2. ICU Length of Stay

    Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days

    Duration of stay in the intensive care unit, measured in days.

  3. Hospital Length of Stay

    Time frame: From hospital admission until hospital discharge or death, assessed up to 28 days

    Total length of hospital stay, measured in days.

  4. Duration of Mechanical Ventilation

    Time frame: From initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 days

    Total duration of invasive mechanical ventilation, measured in days.

  5. Vasopressor Requirement

    Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days

    Requirement for vasopressor support at any time during ICU stay.

  6. Renal Replacement Therapy Requirement

    Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days

    Requirement for renal replacement therapy (RRT) during ICU stay.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: CALLY-FS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 12, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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