Prognostic Value of the CALLY Index in Patients With Sepsis
NCT ID: NCT07285499
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
276 participants
OBSERVATIONAL
2023-01-01
2025-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
CALLY Index values will be obtained on Day 0, Day 3, and Day 5 of ICU admission using routinely collected laboratory data. The primary objective is to determine the association between CALLY Index values and 30-day all-cause mortality. Secondary objectives include assessing the relationship between temporal CALLY changes and the development of acute kidney injury (AKI) within the first 7 days of ICU admission, as well as correlations between the Day-0 CALLY Index and established severity scores such as SOFA and APACHE II.
As this retrospective study uses existing electronic medical records, no additional procedures or interventions will be performed, and no added risk to patients is involved.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This retrospective observational study will include adult patients diagnosed with sepsis according to Sepsis-3 criteria who were admitted to the intensive care unit (ICU) between January 2023 and December 2024. The CALLY Index will be calculated using the following formula:
Albumin (g/L) × lymphocyte count (10⁹/L) × 100 ÷ CRP (mg/L).
CALLY values will be obtained at predefined time points: Day 0 (within 2 hours of ICU admission), Day 3, and Day 5, extracted from the hospital's electronic medical record system.
The primary aim of the study is to evaluate the association between CALLY Index values and 30-day all-cause mortality. Secondary aims include assessing the relationship between temporal changes in CALLY (ΔCALLY₃-₀, ΔCALLY₅-₀, and linear trend slope) and the development of acute kidney injury (AKI) within the first 7 days of ICU admission, as well as examining correlations between the Day-0 CALLY Index and commonly used clinical severity scores, including SOFA and APACHE II.
All study data will be obtained retrospectively from the hospital's electronic records. No additional tests, procedures, or interventions will be performed. As the study utilizes existing clinical data without influencing patient management, it poses no additional risks to participants. The findings may support improved early risk stratification, monitoring of disease progression, and refinement of prognostic assessment in patients with sepsis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sepsis Cohort
Adult ICU patients diagnosed with sepsis according to Sepsis-3 criteria whose CALLY index values were obtained on day 0, day 3, and day 5.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Sepsis diagnosis meeting Sepsis-3 criteria
* ICU stay ≥ 5 days
* Complete CRP, albumin, and lymphocyte laboratory results available for days 0, 3, and 5
Exclusion Criteria
* Liver diseases including cirrhosis, chronic hepatitis, or hepatic failure
* Hematologic diseases such as leukemia, lymphoma, MDS, or multiple myeloma
* Rheumatologic diseases including SLE, rheumatoid arthritis, or systemic sclerosis
* Use of immunosuppressive therapy
* ICU stay shorter than 5 days
* COVID-19 positive status
* Missing laboratory data preventing calculation of CALLY index
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Oğuzhan Demirel
Resident Physician, Department of Anesthesiology and Reanimation
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara University Faculty of Medicine - Intensive Care Unit
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CALLY-Sepsis-2025-01
Identifier Type: -
Identifier Source: org_study_id