Critical IllnessCALLY-FSNCT07579728
CALLY Index, Frailty and SOFA-2 for Mortality Prediction in Geriatric ICU Patients
An observational study of Critical Illness and Frailty, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Critical Illness, Frailty, Intensive Care Unit (ICU)
- What is being tested?
- observational study
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2026to 7 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric patients (aged ≥65 years) admitted to the intensive care unit.
Who may be able to join
- Age ≥65 years
- Admission to the intensive care unit
- Availability of required clinical and laboratory data within the first 24 hours of ICU admission
Who cannot join
- Death within the first 24 hours after ICU admission
- Missing key clinical or laboratory data
- Terminal malignancy receiving palliative care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness, Frailty, Intensive Care Unit (ICU)
- Being tested
- observational study
- Keywords
- CALLY index, frailty, SOFA-2 score, ICU mortality, Geriatric patients
- Medical subject headings
- Critical Illness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
No intervention is applied.This is an observational study in which patients receive standart clinical care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
All-cause mortality occurring during the intensive care unit stay.
Measured: From ICU admission until ICU discharge or death, assessed up to 28 days
Secondary outcomes (6)
28-day Mortality
All-cause mortality within 28 days after ICU admission.
Measured: 28 days
ICU Length of Stay
Duration of stay in the intensive care unit, measured in days.
Measured: From ICU admission until ICU discharge or death, assessed up to 28 days
Hospital Length of Stay
Total length of hospital stay, measured in days.
Measured: From hospital admission until hospital discharge or death, assessed up to 28 days
Duration of Mechanical Ventilation
Total duration of invasive mechanical ventilation, measured in days.
Measured: From initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 days
Vasopressor Requirement
Requirement for vasopressor support at any time during ICU stay.
Measured: From ICU admission until ICU discharge or death, assessed up to 28 days
Renal Replacement Therapy Requirement
Requirement for renal replacement therapy (RRT) during ICU stay.
Measured: From ICU admission until ICU discharge or death, assessed up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start30 Apr 2026
- Primary completion30 Jun 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tugba yesilyurt dogu, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579728
- Sponsor's protocol ID
- KAEK/04.02.2026.82
- Acronym
- CALLY-FS
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly available due to institutional and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of CALLY Index, Frailty and SOFA-2 Score for Mortality in Geriatric Intensive Care Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07579728
- Acronym / sponsor ID
- CALLY-FS / KAEK/04.02.2026.82
- Conditions
- Critical Illness, Frailty, Intensive Care Unit (ICU)
- Keywords
- CALLY index, frailty, SOFA-2 score, ICU mortality, Geriatric patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric ICU patients | – | Other: observational studyGeriatric 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric patients (aged ≥65 years) admitted to the intensive care unit.
Key inclusion criteria (3 listed)
- Age ≥65 years
- Admission to the intensive care unit
- Availability of required clinical and laboratory data within the first 24 hours of ICU admission
Key exclusion criteria (3 listed)
- Death within the first 24 hours after ICU admission
- Missing key clinical or laboratory data
- Terminal malignancy receiving palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyNo intervention is applied.This is an observational study in which patients receive standart clinical care. | Other | Geriatric ICU patients |
Primary outcome
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.
6 secondary outcomes
28-day Mortality
Time frame: 28 days
ICU Length of Stay
Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days
Hospital Length of Stay
Time frame: From hospital admission until hospital discharge or death, assessed up to 28 days
Duration of Mechanical Ventilation
Time frame: From initiation of invasive mechanical ventilation until discontinuation, assessed up to 28 days
Vasopressor Requirement
Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days
Renal Replacement Therapy Requirement
Time frame: From ICU admission until ICU discharge or death, assessed up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly available due to institutional and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Frailty, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: From ICU admission until ICU discharge or death, assessed up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.