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Systemic Immune-Inflamation Index and Mortality in ICU Patients

The Relationship Between Systematic Inflammatory Index (SII) and Mortality in Patients Admitted to the Non-Interventional Clinical Research Ethics Committee for Evalation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07493759
Enrollment
570
Registered
2026-03-25
Start date
2025-12-01
Completion date
2026-03-18
Last updated
2026-03-25

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

Conditions

Critical Illness, Sepsis

Keywords

intensive care unit, systemic immune-inflammation index, mortality

Brief summary

Systemic Immune-Inflammation Index (SII) is a hemogram-derived biomarker reflecting the balance between systemic inflammation and immune response. In critically ill patients, inflammatory burden at admission may play a key role in prognosis. This retrospective cohort study aims to evaluate the association between admission SII levels and intensive care unit (ICU) mortality in adult patients admitted to a reanimation ICU. Secondary objectives include comparison of mortality according to infectious versus non-infectious admission diagnoses and assessment of the relationship between SII and established severity scores, including APACHE II and Glasgow Coma Scale (GCS). The findings may support the use of SII as a rapid, inexpensive prognostic marker in critically ill patients.

Detailed description

Systemic inflammation is a fundamental component of critical illness and has a strong association with disease severity and mortality in intensive care units. The Systemic Immune-Inflammation Index (SII), calculated from neutrophil, lymphocyte, and platelet counts, has emerged as a quantitative marker of systemic immune-inflammatory status. While SII has been studied in various clinical settings, its prognostic value in reanimation ICU patients remains insufficiently defined. This study is designed as a single-center, retrospective, non-interventional cohort study conducted in the Reanimation Intensive Care Unit of Atatürk University Research Hospital. Adult patients (≥18 years) admitted to the ICU for infectious or non-infectious critical illnesses will be evaluated through retrospective review of hospital electronic medical records (ENLİL Hospital Information Management System). Patients will be included if admission laboratory data, including complete blood count and biochemical parameters, are available. Exclusion criteria include pregnancy, hematologic malignancy, active chemotherapy, chronic immunosuppression, pulse steroid therapy, known severe thrombocytopenia (\<50×10⁹/L), massive bleeding or massive transfusion within the first 24 hours, and incomplete clinical or laboratory data. The primary outcome of the study is the association between admission SII levels and ICU mortality. Secondary outcomes include comparison of mortality rates between infectious and non-infectious admission diagnoses, evaluation of correlations between SII and APACHE II and GCS scores, and assessment of whether elevated SII is an independent risk factor for ICU mortality. Sample size calculation was performed using G\*Power software based on a reference population study, assuming a mean SII value of 515±170 in the control group. To detect a 40-unit difference in SII between infectious and non-infectious groups with 80% power and a 95% confidence level, a minimum of 285 patients per group (total ≥570 patients) is required. Statistical analysis will be conducted using appropriate correlation tests (Pearson or Spearman) based on data distribution. As a retrospective, non-interventional study, no additional procedures will be performed, and patient confidentiality will be strictly maintained. The study involves no external funding and no declared conflicts of interest.

Interventions

OTHERSystemic Immune-Inflammation Index (SII)

Systemic immune-inflammation index (SII) calculated at intensive care unit admission using routine complete blood count parameters. SII is calculated as platelet count multiplied by neutrophil count divided by lymphocyte count. Patients are classified into high and low SII groups based on a predefined cutoff value. No therapeutic intervention is administered as part of the study.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

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

Inclusion criteria

* Age 18 years or older * Admission to the reanimation intensive care unit * Availability of admission complete blood count and biochemical laboratory data * Admission due to infectious or non-infectious critical illness

Exclusion criteria

* Pregnancy * Hematologic malignancy * Active chemotherapy * Chronic immunosuppression * Pulse steroid therapy * Known thrombocytopenia (platelet count \<50×10\^9/L) * Massive bleeding or massive transfusion within the first 24 hours of ICU admission * Incomplete clinical or laboratory data

Design outcomes

Primary

MeasureTime frameDescription
ICU Mortality RateDuration of ICU stay (up to 90 days)All-cause mortality during ICU stay, compared between patients with high vs. low SII values

Secondary

MeasureTime frameDescription
Systemic Immune-Inflammation Index (SII)At ICU admission (Day 0)SII calculated as neutrophil count × platelet count / lymphocyte count from admission peripheral blood sample
APACHE II ScoreFirst 24 hours of ICU admissionCorrelation between admission SII level and APACHE II score
Glasgow Coma Scale (GCS) ScoreAt ICU admission (Day 0)Correlation between admission SII level and GCS score

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORnazim doğan, MD

Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026