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Crush SyndromeNCT07433127

Inflammation Indıces and Mortality in Adult Crush Syndrome

An observational study of Crush Syndrome and Rhabdomyolysis, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
325 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2018to 28 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients diagnosed with crush syndrome and admitted to the intensive care unit of Ataturk University Hospital between January 2018 and September 2025.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ataturk University Research Hospital

    Erzurum, 20100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
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, APACHE II, SOFA SCORE, 28-day Mortality, Intensive Care Unit
Medical subject headings
Crush Syndrome, Rhabdomyolysis, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day All-Cause Mortality

    All-cause mortality within 28 days of intensive care unit (ICU) admission in adult patients with crush syndrome.

    Measured: 28 days from ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2026
  2. Study start1 Jan 2018
  3. Primary completion28 Oct 2025
  4. Study completion28 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
325 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07433127
Sponsor's protocol ID
B.30.2.ATA.0.01.00/756
Status last verified
Aug 2026
First submitted
19 Feb 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Crush Syndrome and Rhabdomyolysis, run by Ataturk University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day All-Cause Mortality (time frame: 28 days from ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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