- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433127
Inflammation Indıces and Mortality in Adult Crush Syndrome
The Association of Systemic Inflammation-Based Hematological Indices With APACHE II, SOFA and 28-Day Mortality in Adult Crush Syndrome: A Retrospective Cohort Study
This single-center, retrospective observational cohort study evaluated the prognostic value of complete blood count-derived inflammatory indices - the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index (SII), systemic inflammatory response index (SIRI), and pan-immune-inflammation value (PIV) - for the prediction of 28-day mortality in adult patients with crush syndrome admitted to the intensive care unit (ICU).
Consecutive patients aged 18 years and older who were diagnosed with crush syndrome and admitted to the ICU between January 1, 2018, and September 30, 2025, were included. All indices were calculated from the complete blood count obtained within the first 24 hours of ICU admission. The primary and only outcome was 28-day mortality. The discrimination and independent prognostic value of the inflammatory indices were compared with the APACHE II and SOFA scores, and their incremental value beyond these established severity scores was assessed.
Study Overview
Status
Detailed Description
Crush syndrome is a life-threatening consequence of traumatic rhabdomyolysis, characterized by a systemic inflammatory response, acute kidney injury, electrolyte disturbances, and multi-organ dysfunction, with the highest mortality observed among patients requiring intensive care. Early and objective risk stratification is essential for guiding fluid resuscitation, informing the timing of renal replacement therapy, and allocating critical care resources.
In this single-center, retrospective cohort study, adult patients (≥18 years) diagnosed with crush syndrome and admitted to the intensive care unit of Ataturk University Research Hospital between January 1, 2018, and September 30, 2025, were identified from the hospital electronic health information system. The diagnosis was based on a compatible history of crush injury together with a serum creatine kinase level exceeding five times the upper limit of normal. Patients with conditions that directly alter hematological indices - hematological malignancy, active chemotherapy, chronic immunosuppressive therapy, massive transfusion within the first 24 hours, or known thrombocytopenia - were excluded. Demographic data, complete blood count parameters, and disease-severity scores were retrieved from electronic medical records.
The following inflammatory indices were calculated from the complete blood count obtained within the first 24 hours of ICU admission: NLR (neutrophils/lymphocytes), PLR (platelets/lymphocytes), MLR (monocytes/lymphocytes), SII (platelets × neutrophils/lymphocytes), SIRI (neutrophils × monocytes/lymphocytes), and PIV (neutrophils × platelets × monocytes/lymphocytes).
The primary and only endpoint was 28-day mortality following ICU admission. Group comparisons were performed using the Mann-Whitney U and Student t tests. Discrimination for 28-day mortality was assessed by receiver operating characteristic (ROC) curve analysis, and the areas under the curve were compared with the DeLong test. Because the six indices are deterministic ratios of four blood-count components and are therefore highly collinear, each index was entered into a separate logistic regression model together with the APACHE II and SOFA scores, rather than including all indices in a single model. The incremental discriminatory value of each index beyond an APACHE II plus SOFA base model was quantified as the change in the area under the curve, and internal validity was examined by bootstrapping. The study aimed to determine whether these readily available hematological indices provide prognostic value beyond established severity scores in critically ill patients with crush syndrome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Erzurum, Turkey (Türkiye), 20100
- Ataturk University Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Diagnosis of crush syndrome based on clinical and laboratory findings
- Admission to the intensive care unit (ICU) between January 1, 2018 and September 30, 2025
- Availability of complete blood count parameters within the first 24 hours of ICU admission
Exclusion Criteria:
- Age <18 years
- Incomplete medical records
- Missing laboratory data required for calculation of inflammatory indices
- Patients discharged or transferred within 24 hours of ICU admission
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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28-day All-Cause Mortality
Time Frame: 28 days from ICU admission
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All-cause mortality within 28 days of intensive care unit (ICU) admission in adult patients with crush syndrome.
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28 days from ICU admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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ICU Mortality
Time Frame: During ICU stay (up to 28 days)
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Death occurring during the intensive care unit stay.
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During ICU stay (up to 28 days)
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In-Hospital Mortality
Time Frame: During hospital stay (up to 90 days)
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All-cause mortality occurring during the index hospital admission.
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During hospital stay (up to 90 days)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ATA.0.01.00/756
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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