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IL-6 and Hemogram-Derived Inflammatory Indices for Mortality Prediction in Postoperative ICU Patients

The Effects of IL-6 and Inflammation Scores on Mortality in Postoperative Patients Admitted to the Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07460141
Enrollment
42
Registered
2026-03-10
Start date
2025-12-15
Completion date
2026-03-15
Last updated
2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Inflammation, Intensive Care Unit Admission, Postoperative Complications

Keywords

Interleukin-6, IL-6, Inflammatory indices, Postoperative, Intensive care, Mortality, Biomarkers

Brief summary

This prospective observational cohort study aims to evaluate the predictive value of interleukin-6 (IL-6) levels and hemogram-derived inflammatory scores for morbidity and in-hospital mortality in postoperative patients admitted to the intensive care unit (ICU). IL-6 levels and inflammatory indices will be assessed at ICU admission and at 24 hours using data obtained from routine clinical care. Associations between these biomarkers and clinical outcomes, including mortality, morbidity, antibiotic use, and duration of mechanical ventilation, will be evaluated after adjustment for illness severity.

Detailed description

This prospective observational cohort study will include adult postoperative patients admitted to the intensive care unit (ICU). The study is purely observational, and no additional interventions or procedures will be performed beyond routine clinical care. Interleukin-6 (IL-6) levels will be recorded at ICU admission (0 hour) and at 24 hours. Routine laboratory parameters obtained during standard clinical follow-up, including complete blood count, C-reactive protein (CRP), and albumin levels, will be used to calculate hemogram-derived inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), systemic inflammation response index (SIRI), neutrophil-to-monocyte ratio (NMR), CRP-to-albumin ratio (CAR), CRP-to-lymphocyte ratio (CLR), and the modified systemic inflammation score (mSIS). Illness severity and comorbidity burden will be assessed using established scoring systems, including the Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA), and the Charlson Comorbidity Index. Demographic characteristics, surgical variables (type and duration of surgery), and clinical outcomes will be prospectively recorded. The primary objective is to evaluate the predictive value of IL-6 levels and inflammatory indices for in-hospital mortality. Secondary objectives include associations with postoperative morbidity, infectious complications, antibiotic use, duration of mechanical ventilation, organ dysfunction, and ICU length of stay. Changes in IL-6 levels and inflammatory indices between ICU admission and 24 hours will also be explored.

Interventions

None listed

Sponsors

Ezgi Günaydın
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years * Postoperative patients admitted to the ICU * Availability of complete clinical and laboratory data at ICU admission and at 24 hours * Provision of informed consent by the patient or legally authorized representative

Exclusion criteria

* Age \< 18 years * Thoracic surgery patients * Cardiac surgery patients

Design outcomes

Primary

MeasureTime frameDescription
In-hospital mortality (all-cause)Within 28 days of ICU admissionIn-hospital all-cause mortality within 28 days of intensive care unit admission, assessed using routinely collected clinical data.
Postoperative morbidityWithin 28 daysPostoperative morbidity within 28 days of intensive care unit admission. Postoperative morbidity includes sepsis defined according to Sepsis-3 criteria and acute kidney injury defined according to KDIGO criteria, assessed using routinely collected clinical data.

Secondary

MeasureTime frameDescription
Infectious complications / sepsisWithin 28 daysDevelopment of infectious complications, including sepsis defined according to Sepsis-3 criteria, during the hospital stay within 28 days of ICU admission.
Antibiotic useWithin 28 daysUse of systemic antibiotic therapy during the hospital stay, assessed within 28 days of intensive care unit admission using routinely recorded clinical data.
Duration of mechanical ventilationWithin 28 daysDuration of invasive mechanical ventilation, measured as total number of days of ventilatory support within 28 days following intensive care unit admission.
ICU length of stayWithin 28 daysLength of stay in the intensive care unit, defined as the number of days from ICU admission to ICU discharge.

Countries

Turkey (Türkiye)

Contacts

CONTACTEzgi Günaydın, MD
ezgunaydin@gmail.com+905336834198

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026