Markers of Tissue Injury and Rhabdomyolysis in Patients With Major Trauma

NCT03986736 | Completed

• 2 other identifiers: FNO-KARIM-11-RhabdomyolysisRVO-FNOs/2019-19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Major trauma is associated with a release of alarmins (DAMPs - damage-associated molecular patterns) from the injured tissues. This process results in the activation of the immune system, which is one of the main mechanisms participating in the development of organ dysfunctions in patients with major trauma.

Conditions

Tissue Injury; Major Trauma; Rhabdomyolysis

Keywords

rhabdomyolysis; tissue injury; alarmins; major trauma; acute kidney injury

Outcome Measures

Primary Outcomes (5)

• Correlation between HMGB-1 and sCK/sMb levels

  Correlation between HMGB-1 and sCK/sMb levels will be assessed.

  24 hours

• Correlation between sCK/sMb levels in relation to the degree and localisation of injury

  Correlation between sCK/sMb levels in relation to the degree and localisation of injury will be assessed according to the AIS and ISS scoring scales.

  24 hours

• Mutual comparison of predictive levels of sCK/sMb in relation to post-injury acute kidney injury defined by KDIGO criteria

  Mutual comparison of predictive levels of sCK/sMb in relation to development of post-injury acute kidney injury (defined by KDIGO criteria based both on serum creatine level investigated daily and urine output collected hourly from time of admission to Day 8 after injury) development will be assessed.

  8 days

• Mutual comparison of predictive levels of sCK/sMb in relation to serum and urine AKI biomarkers neutropil-gelatinase associated lipocalin (NGAL)

  Mutual comparison of predictive levels of sCK/sMb in relation to serum and urine AKI biomarker NGAL will be assessed.

  8 days

• Comparison of predictive levels of serum and urine NGAL in relation to post-injury acute kidney injury development defined by KDIGO criteria.

  Comparison of predictive levels of serum and urine NGAL in relation to post-injury acute kidney injury (defined by KDIGO criteria based both on serum creatine level investigated daily and urine output collected hourly from time of admission to Day 8 after injury) development will be assessed.

  8 days

Secondary Outcomes (2)

• Reliability of HMGB-1 in predicting major blood loss in patients with severe trauma

  8 days

• Reliability of HMGB-1 and other DAMPS in predicting organ dysfunction in intensive care unit patients

  8 days

Study Arms (1)

Patients with major trauma

Patients with major trauma will be included in the study.

Diagnostic Test: Laboratory analysis - upon admission; Diagnostic Test: Laboratory analysis - 24 hours after injury

Interventions

Laboratory analysis - upon admission DIAGNOSTIC_TEST

Laboratory analysis will be performed upon admission of the patient to the hospital. Levels of the following parameters will be determined: HMGB-1, sCK, sMb, serum NGAL, and urine NGAL

Patients with major trauma

Laboratory analysis - 24 hours after injury DIAGNOSTIC_TEST

Laboratory analysis will be performed upon admission of the patient to the hospital. Levels of the following parameters will be determined: sCK, sMb, serum NGAL, and urine NGAL

Patients with major trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of polytrauma.

You may qualify if:

• diagnosis of polytrauma
• ISS ≥ 16

You may not qualify if:

• history of a significant kidney impairment
• pregnancy
• injuries incompatible with life, with anticipated survival \< 24 hours
• transfer to palliative care within the first 24 hours after injury
• death within the first 24 hours after injury

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Related Publications (1)

• Frelich M, Bebej M, Pavlicek J, Bursa F, Vodicka V, Svagera Z, Konde A, Jor O, Bilena M, Romanova T, Sklienka P. HMGB-1 as a predictor of major bleeding requiring activation of a massive transfusion protocol in severe trauma. Sci Rep. 2025 Feb 7;15(1):4651. doi: 10.1038/s41598-025-89139-1.

  PMID: 39920329 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Two collections of full blood will be performed in the study subjects for laboratory analysis.

MeSH Terms

Conditions

Rhabdomyolysis; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michal Frelich, MD,PhD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 14, 2019
• Study Start: June 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)