SepsisCALLY-SEPNCT07285499
Prognostic Value of the CALLY Index in Patients With Sepsis
An observational study of Sepsis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sepsis
- How many people
- 276 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2025
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult ICU patients diagnosed with sepsis and treated at Ankara University Medical Faculty Hospital.
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine - Intensive Care Unit
Ankara, 06100
About this study
Official title: Prognostic Value of the CALLY Index in Intensive Care Patients Diagnosed With Sepsis: A Retrospective Cohort Study
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.
Read the detailed description
Sepsis is a life-threatening condition characterized by a dysregulated host response to infection and is frequently associated with multiorgan dysfunction and high mortality. Early identification of patients at increased risk of poor outcomes remains a major challenge in critical care. The C-reactive protein-albumin-lymphocyte (CALLY) Index is a composite biomarker that reflects inflammatory, nutritional, and immune status. Although recent studies have explored the prognostic value of CALLY in critically ill populations, the significance of serial measurements and temporal changes in patients with sepsis has not been fully established.
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
- Sepsis
- Keywords
- CALLY Index, Sepsis, Intensive Care Unit, Mortality, Acute Kidney Injury, SOFA Score, APACHE II
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after ICU admission
Secondary outcomes (3)
Acute Kidney Injury (AKI) Development
Occurrence of acute kidney injury (AKI) during ICU admission, defined according to KDIGO criteria (increase in serum creatinine or decrease in urine output). Unit of measure: Number of participants with AKI. CALLY Index values and temporal CALLY changes (ΔCALLY_3-0 and ΔCALLY_5-0) will be analyzed as predictor variables, but they are not part of this outcome measure.
Measured: Up to 7 days after ICU admission
Correlation Between CALLY Index Trends and Clinical Outcomes (Mortality and AKI)
This outcome will assess the correlation between temporal changes in the CALLY Index and clinical outcomes (30-day mortality and AKI).
CALLY Index will be calculated using the formula:
Albumin (g/L) × lymphocyte count (10⁹/L) × 100 ÷ CRP (mg/L).
Temporal CALLY changes will include:
- ΔCALLY₃-₀ (difference between Day-3 and Day-0 values),
- ΔCALLY₅-₀ (difference between Day-5 and Day-0 values),
- CALLY trend slope (calculated using linear regression across Day-0, Day-3, and Day-5 values).
These variables will be used as predictor variables in prognostic analyses. Unit of measure: Correlation coefficient
Measured: Day 0 to Day 5 (first 5 ICU days)
Correlation Between Day-0 CALLY Index and Severity Scores (SOFA, APACHE II)
This outcome will assess the correlation coefficient between the Day-0 CALLY Index and severity scores (SOFA and APACHE II).
The CALLY Index will be calculated as: Albumin (g/L) × lymphocyte count (10⁹/L) × 100 ÷ CRP (mg/L), using laboratory results obtained within 2 hours of ICU admission (Day 0).
SOFA score will be measured using the standard Sequential Organ Failure Assessment scale (range: 0-24).
APACHE II score will be calculated using the established APACHE II scoring system (range: 0-71).
Unit of measure: Correlation coefficient
Measured: Day 0 (within 2 hours of ICU admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe 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
- Retrospective
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuzhan Demirel, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285499
- Sponsor's protocol ID
- CALLY-Sepsis-2025-01
- Acronym
- CALLY-SEP
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of the CALLY Index in Intensive Care Patients Diagnosed With Sepsis: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07285499
- Acronym / sponsor ID
- CALLY-SEP / CALLY-Sepsis-2025-01
- Conditions
- Sepsis
- Keywords
- CALLY Index, Sepsis, Intensive Care Unit, Mortality, Acute Kidney Injury, SOFA Score, APACHE II
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 16 Dec 2025 (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 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.
Detailed description
Sepsis is a life-threatening condition characterized by a dysregulated host response to infection and is frequently associated with multiorgan dysfunction and high mortality. Early identification of patients at increased risk of poor outcomes remains a major challenge in critical care. The C-reactive protein-albumin-lymphocyte (CALLY) Index is a composite biomarker that reflects inflammatory, nutritional, and immune status. Although recent studies have explored the prognostic value of CALLY in critically ill populations, the significance of serial measurements and temporal changes in patients with sepsis has not been fully established.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult ICU patients diagnosed with sepsis and treated at Ankara University Medical Faculty Hospital.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
Key exclusion criteria (8 listed)
- • Chronic Kidney Disease stage ≥3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30-day All-Cause Mortality
Time frame: 30 days after ICU admission
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.
3 secondary outcomes
Acute Kidney Injury (AKI) Development
Time frame: Up to 7 days after ICU admission
Correlation Between CALLY Index Trends and Clinical Outcomes (Mortality and AKI)
Time frame: Day 0 to Day 5 (first 5 ICU days)
Correlation Between Day-0 CALLY Index and Severity Scores (SOFA, APACHE II)
Time frame: Day 0 (within 2 hours of ICU admission)
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 16 Dec 2025.
- Individual participant dataSharing planned: No
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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 Sepsis, run by Ankara University 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 4 inclusion and 8 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 16 Dec 2025. 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?
30-day All-Cause Mortality (time frame: 30 days after ICU admission). 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 16 Dec 2025.