NCT07208110

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Jan 2026Dec 2028

First Submitted

Initial submission to the registry

September 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

2.9 years

First QC Date

September 28, 2025

Last Update Submit

November 18, 2025

Conditions

Keywords

TraumaWounds and InjuriesIntensive Care UnitsTrauma RegistryLow-Middle Income CountriesColombia

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Discharge by death or within 30 days of ICU length of stay.

    30 days

Secondary Outcomes (1)

  • ICU length of stay

    30 days

Study Arms (2)

Trauma

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

Other: Exposed to trauma

Non-trauma

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

Other: Not exposed

Interventions

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

Trauma

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

Non-trauma

Eligibility Criteria

Age15 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Records of patient discharged from the intensive care unit.

You may qualify if:

  • Admitted to the intensive care unit.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesAccidental Injuries

Study Officials

  • Norton Perez Gutierrez, MD

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

    STUDY DIRECTOR

Central Study Contacts

Norton Perez Gutierrez, MD

CONTACT

Emma I Rodriguez Darabos, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 28, 2025

First Posted

October 6, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

The dataset contains reserved information of patients.

Locations