- 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 retrospective observational cohort study aims to evaluate the prognostic value of inflammatory hematological indices, including 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), in predicting 28-day mortality in adult patients with crush syndrome admitted to the intensive care unit (ICU).
Patients aged 18 years and older diagnosed with crush syndrome between January 1, 2018, and September 30, 2025, were included. The primary outcome is 28-day mortality. Secondary outcomes include ICU mortality and in-hospital mortality. The predictive performance of inflammatory indices will be compared with established severity scores such as APACHE II and SOFA.
Study Overview
Status
Detailed Description
Crush syndrome is a life-threatening condition characterized by severe muscle injury, systemic inflammatory response, acute kidney injury, and high mortality, particularly in disaster-related mass trauma settings. Early risk stratification is crucial for optimizing intensive care management and resource allocation.
This retrospective cohort study includes adult patients (≥18 years) diagnosed with crush syndrome and admitted to the intensive care unit of Ataturk University Hospital between January 1, 2018, and September 30, 2025. Demographic data, laboratory parameters, and clinical severity scores were obtained from electronic medical records.
Inflammatory indices calculated from complete blood count parameters include:
- 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)
- Pan-immune-inflammation value (PIV)
The primary endpoint is 28-day mortality following ICU admission. Secondary endpoints include ICU mortality and in-hospital mortality. Multivariate logistic regression and receiver operating characteristic (ROC) curve analyses will be performed to assess the independent prognostic value of inflammatory indices compared with established scoring systems such as APACHE II and SOFA.
The study aims to determine whether readily available hematological indices provide additional prognostic value in critically ill patients with crush syndrome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Erzurum, Turkey (Türkiye), 20100
- Atatürk 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 |
|---|---|---|
|
28-day All-Cause Mortality
Time Frame: 28 Days
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All-cause mortality occurring within 28 days after intensive care unit (ICU) admission in adult patients diagnosed with crush syndrome.
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28 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ICU Mortality
Time Frame: During ICU stay (up to 28 days)
|
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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