Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:12 AM
Study NCT ID:
NCT07493759
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Systemic Immune-Inflamation Index and Mortality in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 570}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-21', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-03-21', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU Mortality Rate', 'timeFrame': 'Duration of ICU stay (up to 90 days)', 'description': 'All-cause mortality during ICU stay, compared between patients with high vs. low SII values'}], 'secondaryOutcomes': [{'measure': 'Systemic Immune-Inflammation Index (SII)', 'timeFrame': 'At ICU admission (Day 0)', 'description': 'SII calculated as neutrophil count × platelet count / lymphocyte count from admission peripheral blood sample'}, {'measure': 'APACHE II Score', 'timeFrame': 'First 24 hours of ICU admission', 'description': 'Correlation between admission SII level and APACHE II score'}, {'measure': 'Glasgow Coma Scale (GCS) Score', 'timeFrame': 'At ICU admission (Day 0)', 'description': 'Correlation between admission SII level and GCS score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care unit', 'systemic immune-inflammation index', 'mortality'], 'conditions': ['Critical Illness', 'Sepsis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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).\n\nPatients 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.\n\nThe 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.\n\nSample 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.\n\nStatistical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 years or older admitted to the reanimation intensive care unit for infectious or non-infectious critical illness, with available admission laboratory data', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Admission to the reanimation intensive care unit\n* Availability of admission complete blood count and biochemical laboratory data\n* Admission due to infectious or non-infectious critical illness\n\nExclusion Criteria:\n\n* Pregnancy\n* Hematologic malignancy\n* Active chemotherapy\n* Chronic immunosuppression\n* Pulse steroid therapy\n* Known thrombocytopenia (platelet count \\<50×10\\^9/L)\n* Massive bleeding or massive transfusion within the first 24 hours of ICU admission\n* Incomplete clinical or laboratory data'}, 'identificationModule': {'nctId': 'NCT07493759', 'briefTitle': 'Systemic Immune-Inflamation Index and Mortality in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Relationship Between Systematic Inflammatory Index (SII) and Mortality in Patients Admitted to the Non-Interventional Clinical Research Ethics Committee for Evalation', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/804'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'High Systemic Immune-Inflammation Index (High SII)', 'description': 'Critically ill patients admitted to the intensive care unit with a systemic immune-inflammation index (SII) above the predefined cutoff value calculated at ICU admission. SII is calculated as platelet count × neutrophil count / lymphocyte count. Outcomes including ICU mortality are evaluated observationally without any intervention.', 'interventionNames': ['Other: Systemic Immune-Inflammation Index (SII)']}, {'label': 'Low Systemic Immune-Inflammation Index (Low SII)', 'description': 'Critically ill patients admitted to the intensive care unit with a systemic immune-inflammation index (SII) at or below the predefined cutoff value calculated at ICU admission. SII is calculated as platelet count × neutrophil count / lymphocyte count. Outcomes including ICU mortality are evaluated observationally without any intervention.', 'interventionNames': ['Other: Systemic Immune-Inflammation Index (SII)']}], 'interventions': [{'name': 'Systemic Immune-Inflammation Index (SII)', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['High Systemic Immune-Inflammation Index (High SII)', 'Low Systemic Immune-Inflammation Index (Low SII)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Faculty of Medicine Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'nazim doğan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Nazim Dogan Prof. M.D', 'investigatorAffiliation': 'Ataturk University'}}}}