Mortality of Trauma in the Intensive Care Unit. | NCT07208110

Studies
Mortality of Trauma in the Intensive Care Unit.

NCT07208110

Sponsor

Hospital Departamental de Villavicencio

Status

Recruiting

Last Update Posted

May 27, 2026Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

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

Interventions

Exposed to trauma
Not exposed

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2026Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Sep 28, 2025

First Submission Date that Met QC Criteria

Sep 28, 2025

First Posted Date

Oct 6, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2026

Last Update Posted Date

May 27, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Norton Perez-Gutierrez, MD, Principal investigator, Hospital Departamental de VillavicencioPrincipal Investigator

Lead Sponsor

Hospital Departamental de VillavicencioOTHER

Collaborators

Name	Class
Cooperative University of Colombia	OTHER
Clínica Primavera	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Exposed to trauma	Other	Patients exposed to trauma previous to the admission to the ICU.	Trauma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Discharge by death or within 30 days of ICU length of stay.	30 days

Secondary Outcomes

Measure	Description	Time Frame
ICU length of stay	Length of stay in the intensive care unit.	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Admitted to the intensive care unit.

Exclusion Criteria:

None.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Records of patient discharged from the intensive care unit.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Norton Perez Gutierrez, MD	Contact	+573112517471		norton.perez@hotmail.com
Emma I Rodriguez Darabos, MSc	Contact	3112517538		emmaisa1@hotmail.com

Overall Officials

Name	Affiliation	Role
Norton Perez Gutierrez, MD	Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Departamental de Villavicencio	Recruiting	Villavicencio	Meta Department	50001	Colombia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40527820	Result	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.
40214785	Result	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.

ID	Term
D014947	Wounds and Injuries
D000081084	Accidental Injuries