Mortality of Trauma in the Intensive Care Unit.

NCT ID: NCT07208110

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

Brief Summary

In this study, it was planned to establish the factors associated with severe trauma discharged from the intensive care unit and mortality. A cross-sectional trial will be conducted to review the ICU discharge database at a two-year interval to review records of trauma admissions patients and compare them with other types of admissions. Participant institutions are general hospitals (public and private) from the Colombian Orinoco region. the prevalence of admission by trauma will also be determined.

Detailed Description

Introduction Trauma is the main cause of mortality and disability in young population worldwide. The violence and vehicle accidents are the most common mechanism, depending on regional context. Severe cases require admission to the intensive care unit usually. Comprehension of such the factors associated with trauma mortality will allow to optimize, prioritize and improve limited resources, by stratifying the risk, and focus therapeutic strategies, with a potential reduction on mortality, cost, and sequalae. The study aims to analyze the factors associated with outcomes in patients with severe trauma admitted to the intensive care unit.

Methodology An analytical cross-sectional trial will be performed, based on the review of discharge database in the intensive care unit during the period of study. The study will be performed in Hospital Departamental de Villavicencio and Clinica Primavera from January 2022 and December 2024. Al records from discharges will be reviewed to establish those related to trauma indications; the records will be divided in two groups for comparisons between the care after trauma and other admissions. Demographic variables of severity and diagnosis will be analyzed. The outcomes to evaluate will be mortality and ICU length of stay.

Expected results The cause of admission by trauma, severity scores by diagnostic groups, and the outcomes by type of trauma will be highlighted with this trial. With the advance of this research, we expect that predictive variables for mortality in trauma, polytrauma, and major trauma in the ICU, will be revealed, and a predictive model adjusted to the local context of the population cared will be established.

Conditions

Trauma (Including Fractures); Trauma ICU Patients; Trauma Injury; Trauma Patients in ICU; Trauma Patients

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Trauma

Records of patients admitted to the ICU with a diagnosis of trauma, major trauma, polytrauma, severe trauma.

Exposed to trauma

Intervention Type: OTHER

Patients exposed to trauma previous to the admission to the ICU.

Non-trauma

Records of patients admitted to the ICU with other non-trauma diagnosis.

Not exposed

Intervention Type: OTHER

Patients not exposed to trauma previous to the admission to the ICU.

Interventions

Exposed to trauma

Patients exposed to trauma previous to the admission to the ICU.

Intervention Type: OTHER

Not exposed

Patients not exposed to trauma previous to the admission to the ICU.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admitted to the intensive care unit.

Exclusion Criteria

• None.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cooperative University of Colombia

OTHER

Sponsor Role: collaborator

Clínica Primavera

UNKNOWN

Sponsor Role: collaborator

Hospital Departamental de Villavicencio

OTHER

Sponsor Role: lead

Responsible Party

Norton Perez-Gutierrez, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norton Perez Gutierrez, MD

Role: STUDY_DIRECTOR

Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera

Locations

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, Colombia

Countries

Colombia

Central Contacts

Norton Perez Gutierrez, MD

Role: CONTACT

norton.perez@hotmail.com

+573112517471

Emma I Rodriguez Darabos, MSc

Role: CONTACT

emmaisa1@hotmail.com

3112517538

Facility Contacts

Norton Perez Gutierrez, MD

Role: primary

norton.perez@hotmail.com

3112517471

References

Wang F, Li ZM, Ma T. Construction and validation of a nomogram prediction model for the need for intensive care unit admission after hip fracture surgery. Medicine (Baltimore). 2025 Jun 13;104(24):e42793. doi: 10.1097/MD.0000000000042793.

Reference Type: RESULT

PMID: 40527820 (View on PubMed)

Valcarcel CR, Bieler D, Bass GA, Gaarder C, Hildebrand F; ESTES Polytrauma Consensus Group. ESTES recommendations for the treatment of polytrauma-a European consensus based on the German S3 guidelines for the treatment of patients with severe/multiple injuries. Eur J Trauma Emerg Surg. 2025 Apr 11;51(1):171. doi: 10.1007/s00068-025-02852-4.

Reference Type: RESULT

PMID: 40214785 (View on PubMed)

Nunes Dos Santos MS, Stayt LC. The effectiveness of FOUR score versus GCS scale in predicting mortality and morbidity in traumatic brain injured patients in intensive care: A systematic review. Intensive Crit Care Nurs. 2025 Aug;89:104048. doi: 10.1016/j.iccn.2025.104048. Epub 2025 May 7.

Reference Type: RESULT

PMID: 40339389 (View on PubMed)

Chen Y, Wei X, Sun X, Mo X, Tu J, Xie T. Development and validation of a practical predicting model for early mortality in polytrauma patients: secondary analysis from Switzerland. BMJ Open. 2025 Jun 12;15(6):e100417. doi: 10.1136/bmjopen-2025-100417.

Reference Type: RESULT

PMID: 40506077 (View on PubMed)

Hefny AF, Idris K, Eid HO, Abu-Zidan FM. Factors affecting mortality of critical care trauma patients. Afr Health Sci. 2013 Sep;13(3):731-5. doi: 10.4314/ahs.v13i3.30.

Reference Type: RESULT

PMID: 24250314 (View on PubMed)

Fukuchi M, Nakajima M, Fukai Y, Miyazaki T, Masuda N, Sohda M, Manda R, Tsukada K, Kato H, Kuwano H. Increased expression of c-Ski as a co-repressor in transforming growth factor-beta signaling correlates with progression of esophageal squamous cell carcinoma. Int J Cancer. 2004 Mar 1;108(6):818-24. doi: 10.1002/ijc.11651.

Reference Type: RESULT

PMID: 14712482 (View on PubMed)

Other Identifiers

GRIVI_2025_01_QX_UCI_TMA

Identifier Type: -

Identifier Source: org_study_id