Prognostic Value of the CALLY Index in Patients With Sepsis

NCT07285499 | Completed

• 1 other identifier: CALLY-Sepsis-2025-01
• Study Type: observational
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational study evaluates the prognostic value of the C-reactive protein-albumin-lymphocyte (CALLY) index in adult patients with sepsis admitted to the intensive care unit (ICU). The CALLY index reflects inflammatory, nutritional, and immunologic status and may serve as a predictor of clinical outcomes. 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.

Conditions

Sepsis

Keywords

CALLY Index; Sepsis; Intensive Care Unit; Mortality; Acute Kidney Injury; SOFA Score; APACHE II

Outcome Measures

Primary Outcomes (1)

• 30-day All-Cause Mortality

  Proportion of adult ICU patients with sepsis who die from any cause within 30 days after ICU admission. Vital status at 30 days will be obtained exclusively from the hospital electronic medical record system. Unit of measure: Percentage of participants. The CALLY Index will be calculated as: Albumin (g/L) × lymphocyte count (10⁹/L) × 100 ÷ CRP (mg/L). CALLY Index values measured on Day 0, Day 3, and Day 5 will be used as predictor variables in prognostic analyses, but they are not part of this outcome measure.

  30 days after ICU admission

Secondary Outcomes (3)

• Acute Kidney Injury (AKI) Development

  Up to 7 days after ICU admission

• Correlation Between CALLY Index Trends and Clinical Outcomes (Mortality and AKI)

  Day 0 to Day 5 (first 5 ICU days)

• Correlation Between Day-0 CALLY Index and Severity Scores (SOFA, APACHE II)

  Day 0 (within 2 hours of ICU admission)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult ICU patients diagnosed with sepsis and treated at Ankara University Medical Faculty Hospital.

You may qualify if:

• Age ≥ 18 years
• Sepsis diagnosis meeting Sepsis-3 criteria
• ICU stay ≥ 5 days
• Complete CRP, albumin, and lymphocyte laboratory results available for days 0, 3, and 5

You may not qualify if:

• Chronic Kidney Disease stage ≥3
• 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

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine - Intensive Care Unit

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sepsis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician, Department of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)