Trauma (Including Fractures)MOTRAM-ICU-COLNCT07208110
Mortality of Trauma in the Intensive Care Unit.
An observational study of Trauma (Including Fractures) and Trauma ICU Patients, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 100 years
- Conditions the study is for
- Trauma (Including Fractures), Trauma ICU Patients, Trauma Injury
- What is being tested?
- Exposed to trauma and Not exposed
- How many people
- 500 participants
- Where
- 1 siteColombia
- Study dates
- 30 Jan 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Records of patient discharged from the intensive care unit.
Who may be able to join
- Admitted to the intensive care unit.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
Norton Perez Gutierrez, MD, 3112517471, norton.perez@hotmail.com
About this study
Official title: Factors Associated With Mortality by Trauma in the Intensive Care Unit in Villavicencio, Colombia. A Trial Based on a Discharge Registry.
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.
Read the 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
- Being tested
- Exposed to trauma, Not exposed
- Keywords
- Trauma, Wounds and Injuries, Intensive Care Units, Trauma Registry, Low-Middle Income Countries, Colombia
- Medical subject headings
- Wounds and Injuries, Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposed to traumaOther
Patients exposed to trauma previous to the admission to the ICU.
Not exposedOther
Patients not exposed to trauma previous to the admission to the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Trauma | Records of patients admitted to the ICU with a diagnosis of trauma, major trauma, polytrauma, severe trauma. Receives: Other: Exposed to trauma | |
| Non-trauma | Records of patients admitted to the ICU with other non-trauma diagnosis. Receives: Other: Not exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Discharge by death or within 30 days of ICU length of stay.
Measured: 30 days
Secondary outcomes (1)
ICU length of stay
Length of stay in the intensive care unit.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start30 Jan 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Trauma (Including Fractures)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Collaborators
- Cooperative University of Colombia, Clínica Primavera
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez Gutierrez, MD, Study director, Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208110
- Sponsor's protocol ID
- GRIVI_2025_01_QX_UCI_TMA
- Acronym
- MOTRAM-ICU-COL
- Status last verified
- May 2026
- First submitted
- 28 Sep 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset contains reserved information of patients.
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.
PubMed 40527820Valcarcel 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.
PubMed 40214785Nunes 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.
PubMed 40339389Chen 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.
PubMed 40506077Hefny 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.
PubMed 24250314Fukuchi 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.
PubMed 14712482
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Mortality by Trauma in the Intensive Care Unit in Villavicencio, Colombia. A Trial Based on a Discharge Registry.
- ClinicalTrials.gov ID
- NCT07208110
- Acronym / sponsor ID
- MOTRAM-ICU-COL / GRIVI_2025_01_QX_UCI_TMA
- Conditions
- Trauma (Including Fractures), Trauma ICU Patients, Trauma Injury, Trauma Patients in ICU, Trauma Patients
- Keywords
- Trauma, Wounds and Injuries, Intensive Care Units, Trauma Registry, Low-Middle Income Countries, Colombia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Collaborators
- Cooperative University of Colombia, Clínica Primavera
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma | – | Other: Exposed to traumaRecords of patients admitted to the ICU with a diagnosis of trauma, major trauma, polytrauma, severe trauma. |
| Non-trauma | – | Other: Not exposedRecords of patients admitted to the ICU with other non-trauma diagnosis. |
Who may qualify
- Ages
- 15 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Records of patient discharged from the intensive care unit.
Key inclusion criteria (1 listed)
- Admitted to the intensive care unit.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposed to traumaPatients exposed to trauma previous to the admission to the ICU. | Other | Trauma |
| Not exposedPatients not exposed to trauma previous to the admission to the ICU. | Other | Non-trauma |
Primary outcome
Mortality
Time frame: 30 days
Discharge by death or within 30 days of ICU length of stay.
1 secondary outcome
ICU length of stay
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 40527820Wang 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.
- Results publication: PubMed 40214785Valcarcel 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.
- Results publication: PubMed 40339389Nunes 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.
- Results publication: PubMed 40506077Chen 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.
- Results publication: PubMed 24250314Hefny 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.
- Results publication: PubMed 14712482Fukuchi 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.
- Individual participant dataSharing planned: No. The dataset contains reserved information of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norton Perez Gutierrez, MD study director
Universidad Cooperativa de Colombia; Hospital Departamental de Villavicencio; Clínica Primavera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma (Including Fractures) and Trauma ICU Patients, run by Hospital Departamental de Villavicencio at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norton Perez Gutierrez, MD (+573112517471, norton.perez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07208110, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.