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Recruiting NCT07208110

Mortality of Trauma in the Intensive Care Unit.

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exposed to trauma, Not exposed.
Who it may be relevant to
Registry conditions: Trauma (Including Fractures), Trauma ICU Patients, Trauma Injury, Trauma Patients in ICU. Basic parameters: 15 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Factors Associated With Mortality by Trauma in the Intensive Care Unit in Villavicencio, Colombia. A Trial Based on a Discharge Registry.

Overview

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.

Interventions

  • Other Exposed to trauma
    Patients exposed to trauma previous to the admission to the ICU.
  • Other Not exposed
    Patients not exposed to trauma previous to the admission to the ICU.

Primary outcome measures

  • Mortality [Time frame: 30 days]
Secondary outcome measures (1)
  • ICU length of stay [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

  • Admitted to the intensive care unit.

Exclusion criteria

  • None.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Colombia · 1 center
  • Hospital Departamental de Villavicencio — Villavicencio

Publications

  • 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. PMID 40527820
  • 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. PMID 40214785
  • 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. PMID 40339389
  • 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. PMID 40506077
  • 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. PMID 24250314
  • 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. PMID 14712482

Identifiers

NCT: NCT07208110 · GRIVI_2025_01_QX_UCI_TMA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗