NCT07579728

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

May 12, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 30, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

CALLY indexfrailtySOFA-2 scoreICU mortalityGeriatric patients

Outcome Measures

Primary Outcomes (1)

  • ICU Mortality

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

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

Secondary Outcomes (6)

  • 28-day Mortality

    28 days

  • ICU Length of Stay

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

  • Hospital Length of Stay

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

  • Duration of Mechanical Ventilation

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

  • Vasopressor Requirement

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

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: observational study

Interventions

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

Geriatric ICU patients

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Geriatric patients (aged ≥65 years) admitted to the intensive care unit.

You may qualify if:

  • Age ≥65 years
  • Admission to the intensive care unit
  • Availability of required clinical and laboratory data within the first 24 hours of ICU admission

You may not qualify if:

  • Death within the first 24 hours after ICU admission
  • Missing key clinical or laboratory data
  • Terminal malignancy receiving palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Critical IllnessFrailty

Interventions

Observation

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

TUGBA Yesilyurt Dogu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Anesthesiology and Intensive Care

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 12, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

May 12, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly available due to institutional and ethical restrictions.

Locations